45 Regulatory Affairs Job Openings jobs in Hyderabad
RC - REGULATORY COMPLIANCE - REGULATORY COMPLIANCE - Senior
Hyderabad, Andhra Pradesh
EY
Posted today
Job Viewed
Job Description
The opportunity
We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.
Your key responsibilities
Skills and attributes for success
To qualify for the role, you must have
Ideally, you’ll also have
What we look for
What working at EY offers
At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.
You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:
EY | Building a better working world
This advertiser has chosen not to accept applicants from your region.
0
Sr. Specialist Cybersecurity - Regulatory Compliance
Hyderabad, Andhra Pradesh
AT&T
Posted today
Job Viewed
Job Description
**Job Description:**
**Role:** **Senior Specialist - CSO International (EMEA)**
**About the Company:**
At AT&T, we're connecting the world through the latest tech and top-of-the-line communications. Our groundbreaking digital solutions provide intuitive and integrated experiences for millions of customers across online, retail and care channels. Join our mission to deliver compelling communication and entertainment experiences to customers around the world as we continue to evolve as a technology-powered, human-centered organization. As part of our team, you'll transform the way we deliver a seamless customer experience with digital at the center of all you do. In our world, digital is much larger than just an eCommerce channel, we are transforming all channels to digitally perform as one team to create a better customer experience. As we move into 2026, the digital transformation will revolutionize the digital space, and you can build a career that will propel your future.
**About the Job:**
The CSO International function is established to support AT&T management in areas outside the United States in Most of World (MOW) to achieve a secure IT environment by developing, applying, and maintaining effective IT security controls, as well as monitoring, measuring, and reporting business compliance to the applicable IT security controls and business unit leadership.
The professional in this role will have a focus on EMEA region and provide support to maintain compliance with AT&T Security Policies and Standards as well as Regulatory requirements, maintain ISO 27001 certification globally, pre and post audit support, remediation oversight for the issues identified and communication and compliance reporting to leadership.
**Experience Level:** 8+ years.
**Location:** Hyderabad / Bengaluru
**Responsibilities Include:**
Support compliance with AT&T Security Policies and Standards through
+ Security calendar development and communication
+ Security process review and development
+ Self-Assessments
+ Security education - via security awareness events, security tip of the month, and white papers
+ Internal and external customer support - service reviews and attending to security queries and provide consultation etc.
+ Enterprise security health check through tools
+ Managing government, legal and regulatory requests
Maintain ISO27001 Certification globally
+ Perform internal assessments and act as audit interface for external audits
+ Manage closure of identified vulnerabilities
+ Improve Information Management Security System (ISMS) by reviewing effectiveness of ISMS operation
Audit coordination and remediation oversight
+ Pre and post audit support - service and process reviews and sample audit checks. Action plan creation and implementation
+ Monitor closure of vulnerabilities from the security audit/review Program
+ Monitor closure of external audit recommendations
Prepare and present compliance reports and metrics to senior leadership and relevant stakeholders
Monitor regulatory changes in the EMEA region and advise on necessary updates to policies or processes
**Required skills:**
+ Minimum of 8 years of relevant experience
+ Strong knowledge of EMEA regulatory requirements and frameworks
+ Familiarity with ISO 27001 certification process etc.
+ Proven ability to interpret complex regulations and translate them into practical compliance programs
+ Excellent communication, collaboration, and stakeholder management skills.
+ Relevant certifications such as CISM, CISA, CISSP, or CRISC are a plus
+ Strong analytical and problem-solving skills with attention to detail
+ Strong documentation and effective articulation skills
**Desirable skills:**
+ Bachelor's degree in computer science, Mathematics, Information Systems, Engineering or Cyber Security
+ Prior experience with Telecom sector
+ ISACA, ISC2 or other relevant certifications
**Additional information (if any):** Need to be flexible provide coverage during varying hours as needed.
**Weekly Hours:**
40
**Time Type:**
Regular
**Location:**
Hyderabad, India
It is the policy of AT&T to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, AT&T will provide reasonable accommodations for qualified individuals with disabilities. AT&T is a fair chance employer and does not initiate a background check until an offer is made.
AT&T will consider for employment qualified applicants in a manner consistent with the requirements of federal, state and local laws
We expect employees to be honest, trustworthy, and operate with integrity. Discrimination and all unlawful harassment (including sexual harassment) in employment is not tolerated. We encourage success based on our individual merits and abilities without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, disability, marital status, citizenship status, military status, protected veteran status or employment status
**Role:** **Senior Specialist - CSO International (EMEA)**
**About the Company:**
At AT&T, we're connecting the world through the latest tech and top-of-the-line communications. Our groundbreaking digital solutions provide intuitive and integrated experiences for millions of customers across online, retail and care channels. Join our mission to deliver compelling communication and entertainment experiences to customers around the world as we continue to evolve as a technology-powered, human-centered organization. As part of our team, you'll transform the way we deliver a seamless customer experience with digital at the center of all you do. In our world, digital is much larger than just an eCommerce channel, we are transforming all channels to digitally perform as one team to create a better customer experience. As we move into 2026, the digital transformation will revolutionize the digital space, and you can build a career that will propel your future.
**About the Job:**
The CSO International function is established to support AT&T management in areas outside the United States in Most of World (MOW) to achieve a secure IT environment by developing, applying, and maintaining effective IT security controls, as well as monitoring, measuring, and reporting business compliance to the applicable IT security controls and business unit leadership.
The professional in this role will have a focus on EMEA region and provide support to maintain compliance with AT&T Security Policies and Standards as well as Regulatory requirements, maintain ISO 27001 certification globally, pre and post audit support, remediation oversight for the issues identified and communication and compliance reporting to leadership.
**Experience Level:** 8+ years.
**Location:** Hyderabad / Bengaluru
**Responsibilities Include:**
Support compliance with AT&T Security Policies and Standards through
+ Security calendar development and communication
+ Security process review and development
+ Self-Assessments
+ Security education - via security awareness events, security tip of the month, and white papers
+ Internal and external customer support - service reviews and attending to security queries and provide consultation etc.
+ Enterprise security health check through tools
+ Managing government, legal and regulatory requests
Maintain ISO27001 Certification globally
+ Perform internal assessments and act as audit interface for external audits
+ Manage closure of identified vulnerabilities
+ Improve Information Management Security System (ISMS) by reviewing effectiveness of ISMS operation
Audit coordination and remediation oversight
+ Pre and post audit support - service and process reviews and sample audit checks. Action plan creation and implementation
+ Monitor closure of vulnerabilities from the security audit/review Program
+ Monitor closure of external audit recommendations
Prepare and present compliance reports and metrics to senior leadership and relevant stakeholders
Monitor regulatory changes in the EMEA region and advise on necessary updates to policies or processes
**Required skills:**
+ Minimum of 8 years of relevant experience
+ Strong knowledge of EMEA regulatory requirements and frameworks
+ Familiarity with ISO 27001 certification process etc.
+ Proven ability to interpret complex regulations and translate them into practical compliance programs
+ Excellent communication, collaboration, and stakeholder management skills.
+ Relevant certifications such as CISM, CISA, CISSP, or CRISC are a plus
+ Strong analytical and problem-solving skills with attention to detail
+ Strong documentation and effective articulation skills
**Desirable skills:**
+ Bachelor's degree in computer science, Mathematics, Information Systems, Engineering or Cyber Security
+ Prior experience with Telecom sector
+ ISACA, ISC2 or other relevant certifications
**Additional information (if any):** Need to be flexible provide coverage during varying hours as needed.
**Weekly Hours:**
40
**Time Type:**
Regular
**Location:**
Hyderabad, India
It is the policy of AT&T to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, AT&T will provide reasonable accommodations for qualified individuals with disabilities. AT&T is a fair chance employer and does not initiate a background check until an offer is made.
AT&T will consider for employment qualified applicants in a manner consistent with the requirements of federal, state and local laws
We expect employees to be honest, trustworthy, and operate with integrity. Discrimination and all unlawful harassment (including sexual harassment) in employment is not tolerated. We encourage success based on our individual merits and abilities without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, disability, marital status, citizenship status, military status, protected veteran status or employment status
This advertiser has chosen not to accept applicants from your region.
1
AML Regulatory Compliance Analyst - Hyderabad
Hyderabad, Andhra Pradesh
2coms
Posted today
Job Viewed
Job Description
About the Client :
A Fortune 500 global leader in technology services and digitalbusiness solutions, this company delivers comprehensive Business Process Services (BPS) and IT-enabled solutions. With a worldwide presence, it serves diverse industries including banking, healthcare, retail, manufacturing, and communications. The firm's expertise spans a broad spectrum of critical processes—from finance and accounting to human resources, customer service, and supply chain management - enabling clients to enhance efficiency, drive innovation, and achieve business agility on a massive scale.
Position : Subject Matter Expert(SME)
Shift : US Shift | 5 days | Cab will be provided
CTC : Upto LPA
Location : Hyderabad, WFO
Reporting To : Operations Leader / Compliance Lead
Employment Type : Full-time
Role Summary:
The Regulatory Compliance Analyst will be responsible for supporting compliance obligations across various regulatory domains including SEC, FINRA, AML/OFAC, and insurance-related regulations. This role ensures timely and accurate reporting, supports audits and exams, and contributes to maintaining a compliant and risk-aware operational environment.
Key Responsibilities:
Regulatory Oversight & Reporting
Fraud & AML/OFAC Monitoring
Complaints & Escalations
Licensure
Documentation & Governance
Qualifications:
Functional Competencies:
oAbility to prepare and deliver compliance reports (, market conduct exams, subpoenas, TEFRA documentation).
oSkilled in maintaining and updating SOPs and compliance documentation.
oProficient in supporting internal and external audits, including Early Warning Reports.
oFamiliarity with regulatory frameworks such as SEC, FINRA, and insurance-related standards.
oCompetence in conducting fraud investigations using tools like GIACT.
oAbility to monitor and escalate suspicious activities in line with AML/OFAC guidelines.
Technical Competencies
Behavioral Competencies
Certifications (Preferred):
This advertiser has chosen not to accept applicants from your region.
2
Regulatory Affairs
Hyderabad, Andhra Pradesh
LEE PHARMA LTD
Posted 1 day ago
Job Viewed
Job Description
Managing regulatory affairs of the organization its subsidiaries/associates Liaising
with regulatory bodies like State and Central FDA,DCI Well conversant with Drug
law/feed supplement regulation Co-ordination with purchase, marketing departments
Preparation of Applicant part and Restricted part DMFs (USDMF, EUDMF and ROW).
**Salary**: From ₹171,172.50 per year
**Benefits**:
- Health insurance
- Internet reimbursement
- Leave encashment
- Provident Fund
Schedule:
- Day shift
Supplemental pay types:
- Yearly bonus
Ability to commute/relocate:
- Hyderabad, Telangana: Reliably commute or planning to relocate before starting work (required)
with regulatory bodies like State and Central FDA,DCI Well conversant with Drug
law/feed supplement regulation Co-ordination with purchase, marketing departments
Preparation of Applicant part and Restricted part DMFs (USDMF, EUDMF and ROW).
**Salary**: From ₹171,172.50 per year
**Benefits**:
- Health insurance
- Internet reimbursement
- Leave encashment
- Provident Fund
Schedule:
- Day shift
Supplemental pay types:
- Yearly bonus
Ability to commute/relocate:
- Hyderabad, Telangana: Reliably commute or planning to relocate before starting work (required)
This advertiser has chosen not to accept applicants from your region.
3
Regulatory Affairs Mgr
Hyderabad, Andhra Pradesh
Amgen
Posted 15 days ago
Job Viewed
Job Description
**Manager - International Regulatory Lead**
**Role Name: Manager - International Regulatory Lead (IRL)**
**Department Name: International Regulatory Team, Global Regulatory Affairs**
**Role GCF: 5A**
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**ABOUT THE ROLE**
Role Description
The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to
- optimize product development and regulatory approvals in International countries
- develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management.
Roles & Responsibilities
- Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives.
- Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans).
- Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio.
- Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate.
- Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing.
- Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes.
- Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management.
- Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams.
- Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations.
- Partners with peers to agree on product strategy including projected submission and approval time.
- Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status.
- Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function.
- Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products.
- Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
**Basic Qualifications and Experience**
· Doctorate degree OR
· Master's degree and 3 years of relevant regional regulatory experience OR
· Bachelor's degree and 5 years of relevant regional regulatory experience OR
· Associate degree and 10 years of relevant regional regulatory experience OR
· High school diploma/GED and 12 years of relevant regional regulatory experience.
**Functional Skills**
Must-Have Skills
- Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products
- Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes
- General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities.
Good-to-Have Skills
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across country, regional and international borders.
Soft Skills
- Strong communication skills, both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to work effectively with global, local and virtual teams
- High degree of initiative and self-motivation
- Planning and organizing abilities
- Ability to manage multiple priorities successfully
- Team-oriented, with a focus on achieving team goals
- Good negotiation and influencing skills.
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
**Role Name: Manager - International Regulatory Lead (IRL)**
**Department Name: International Regulatory Team, Global Regulatory Affairs**
**Role GCF: 5A**
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**ABOUT THE ROLE**
Role Description
The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to
- optimize product development and regulatory approvals in International countries
- develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management.
Roles & Responsibilities
- Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives.
- Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans).
- Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio.
- Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate.
- Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing.
- Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes.
- Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management.
- Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams.
- Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations.
- Partners with peers to agree on product strategy including projected submission and approval time.
- Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status.
- Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function.
- Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products.
- Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
**Basic Qualifications and Experience**
· Doctorate degree OR
· Master's degree and 3 years of relevant regional regulatory experience OR
· Bachelor's degree and 5 years of relevant regional regulatory experience OR
· Associate degree and 10 years of relevant regional regulatory experience OR
· High school diploma/GED and 12 years of relevant regional regulatory experience.
**Functional Skills**
Must-Have Skills
- Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products
- Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes
- General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities.
Good-to-Have Skills
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across country, regional and international borders.
Soft Skills
- Strong communication skills, both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to work effectively with global, local and virtual teams
- High degree of initiative and self-motivation
- Planning and organizing abilities
- Ability to manage multiple priorities successfully
- Team-oriented, with a focus on achieving team goals
- Good negotiation and influencing skills.
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
This advertiser has chosen not to accept applicants from your region.
4
Regulatory Affairs Manager
Hyderabad, Andhra Pradesh
Amgen
Posted 15 days ago
Job Viewed
Job Description
**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Job Summary:**
Amgen is seeking a Manager, Regulatory Affairs CMC - Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance.
Join us in revolutionizing regulatory submissions through cutting-edge data automation!
**Key Responsibilities:**
+ Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows.
+ Assist in developing standardized templates and structured data formats for consistent and compliant submissions.
+ Contribute to projects focused on the application of AI and structured content/data management (SCDM) for regulatory use cases.
+ Coordinate with cross-functional teams, including Process Development, Quality, and Regulatory Affairs, to ensure alignment on automation and data standards.
+ Monitor industry trends and guidance to maintain up-to-date knowledge on digital and regulatory innovations.
+ Support the design and deployment of automated solutions for data extraction, conversion, and integration with regulatory platforms.
+ Participate in training activities to expand internal capabilities in digital tools and regulatory data automation.
+ Assist in regulatory interactions related to digital transformation, ensuring preparedness for engagement on evolving standards.
**Basic Qualifications:**
+ Doctorate degree OR
+ Master's degree and 3 years of directly related experience OR
+ Bachelor's degree and 5 years of directly related experience
+ Experience managing and leading a team in a regulatory or compliance environment
**Preferred Qualifications:**
+ Degree in life sciences, digital or data science, biochemistry, or chemistry
+ Experience leading global regulatory CMC submissions with knowledge of ICH guidance and global requirements
+ Background or basic experience in digitalization, automation, software development
+ Background in manufacturing, process development, quality control, or quality assurance
+ Hands-on experience with Veeva Vault platforms and regulatory technology solutions.
**What we expect from you**
We are all different, yet we all use our unique contributions to serve patients.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination** Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Job Summary:**
Amgen is seeking a Manager, Regulatory Affairs CMC - Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance.
Join us in revolutionizing regulatory submissions through cutting-edge data automation!
**Key Responsibilities:**
+ Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows.
+ Assist in developing standardized templates and structured data formats for consistent and compliant submissions.
+ Contribute to projects focused on the application of AI and structured content/data management (SCDM) for regulatory use cases.
+ Coordinate with cross-functional teams, including Process Development, Quality, and Regulatory Affairs, to ensure alignment on automation and data standards.
+ Monitor industry trends and guidance to maintain up-to-date knowledge on digital and regulatory innovations.
+ Support the design and deployment of automated solutions for data extraction, conversion, and integration with regulatory platforms.
+ Participate in training activities to expand internal capabilities in digital tools and regulatory data automation.
+ Assist in regulatory interactions related to digital transformation, ensuring preparedness for engagement on evolving standards.
**Basic Qualifications:**
+ Doctorate degree OR
+ Master's degree and 3 years of directly related experience OR
+ Bachelor's degree and 5 years of directly related experience
+ Experience managing and leading a team in a regulatory or compliance environment
**Preferred Qualifications:**
+ Degree in life sciences, digital or data science, biochemistry, or chemistry
+ Experience leading global regulatory CMC submissions with knowledge of ICH guidance and global requirements
+ Background or basic experience in digitalization, automation, software development
+ Background in manufacturing, process development, quality control, or quality assurance
+ Hands-on experience with Veeva Vault platforms and regulatory technology solutions.
**What we expect from you**
We are all different, yet we all use our unique contributions to serve patients.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination** Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation
This advertiser has chosen not to accept applicants from your region.
5
Associate Regulatory Affairs
Hyderabad, Andhra Pradesh
Amgen
Posted 15 days ago
Job Viewed
Job Description
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**ABOUT THE ROLE**
In this essential role, you will oversee the coordination and execution of FDA 2253 reporting submissions, while also serving as Amgen's Digital Asset Management (DAM) librarian. In addition, this role will provide comprehensive administrative support to Operations staff throughout project lifecycles such as label changes. As a cross-functional position, you will collaborate closely with Regulatory Operations, engage with marketing teams as well as creative agencies to drive key commercial objectives. A strong proficiency in graphic design and video editing software-such as Adobe Creative Suite, Premiere Pro, and After Effects-is critical for success in this role. Additionally, proficiency with Veeva Promomats is highly preferred.
**Roles and Responsibilities:**
+ Conduct quality assurance reviews and process the daily release of FDA Form 2253 reportable submissions for promotional materials referencing marketed products.
+ Evaluate creative file submissions and system metadata of marketing materials, ensuring completeness, accuracy, and compliance with licensing requirements.
+ Collaborate with creative agencies and marketing teams to oversee the renegotiation, renewal and collection of usage rights for marketing materials.
+ Leverage company subscriptions to provide art procurement services in support of Amgen's marketing initiatives.
+ Retrieve, validate, and distribute digital asset packages to agencies and marketing teams, utilizing Amgen's various data repositories.
+ Facilitate and participate in stakeholder meetings to ensure adherence to Digital Asset Management (DAM) timelines and processes.
+ Maintain and manage records in Veeva Promomats, RIM and SharePoint; prior experience with SharePoint and Veeva Business Admin certification preferred.
+ Lead and facilitate Webex/MS Teams meetings, including agenda preparation and accurate documentation of meeting minutes.
+ Create infographics and presentation materials; perform technical editing and proofreading of process documentation.
**Required Knowledge and Skills:**
+ Veeva PromoMats and RIM experience.
+ Proficiency in Veeva PromoMats and RIM with hands-on experience navigating the platform to manage promotional and medical content.
+ Strong understanding of Veeva workflows, including initiating, reviewing, approving, and routing materials through the appropriate lifecycle stages.
+ Experience performing quality control (QC) checks on submitted materials to ensure compliance with US regulatory, legal, and brand standards.
+ Ability to update and maintain metadata accurately within Veeva PromoMats and RIM, ensuring consistency with naming conventions, taxonomy, and version control requirements.
+ Proficiency in Veeva digital asset management (DAM) systems and experience handling various file types, metadata, licensing agreements, and usage rights.
+ Familiarity with digital asset management (DAM) best practices, including asset tagging, archiving, and retrieval within Veeva, SharePoint, and BOX.
+ Knowledge of compliance and US FDA regulatory requirements for promotional materials in the pharmaceutical or life sciences industry.
+ Experience troubleshooting and resolving metadata or workflow issues, including collaboration with cross-functional teams (e.g., Regulatory, Marketing, or Creative Agencies).
+ Detail-oriented mindset with the ability to identify discrepancies and ensure data integrity across documents and metadata fields.
+ Comfortable working in a fast-paced, highly regulated environment, managing multiple tasks and priorities within tight deadlines.
+ Strong communication skills to effectively liaise with stakeholders and provide guidance on Amgen's Veeva PromoMats processes and best practices.
+ Experience in Veeva PromoMats to create Electronic Common Technical Documents (eCTD) compliance packages for US FDA 2253 submissions with a strong knowledge of US FDA eCTD publishing tools
+ Has knowledge of the US FDA guidance for submissions of promotional materials.
+ Strong knowledge of Adobe Creative Suite (Photoshop, Illustrator, InDesign) and other design tools.
+ Proficient in Microsoft Office Suite, including PowerPoint, Visio, Excel (with pivot tables), and Word.
+ Proven ability to manage multiple projects simultaneously while meeting deadlines and adhering to established processes.
+ MS Outlook inbox management, including organizational skills, creating email rules, and standard email templates.
+ Develop and maintain clear, structured process documents, SOPs, and workflow guides.
+ Design and run periodic and ad hoc reports using Veeva's reporting functionality to support leadership in the analysis and interpretation of performance data.
**Preferred Knowledge and Skills:**
+ Bachelor's degree in graphic design, visual arts, marketing, or a related creative field.
+ Minimum of +2 years of experience in marketing, pharmaceutical, or healthcare industries, with a strong understanding of regulatory requirements for promotional materials.
+ Veeva Business Admin certification.
+ Experience collaborating with creative agencies and cross-functional teams to facilitate the collection, transfer and distribution of marketing materials.
+ Excellent attention to detail and ability to conduct thorough quality control checks on creative files for promotional content.
+ Understanding FDA regulations and compliance requirements related to marketing materials and submissions.
+ Strong analytical and problem-solving skills to ensure accuracy in digital asset retrieval, troubleshooting of file issues, validation, and distribution.
+ Effective communication and stakeholder management skills to lead and participate in discussions regarding DAM timelines and creative file submission approvals.
**AIN working hours for this position:**
This position supports the Regulatory Promotion and Material Compliance activities serving Amgen's US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications.
**EQUAL OPPORTUNITY STATEMENT**
+ Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
+ We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**ABOUT THE ROLE**
In this essential role, you will oversee the coordination and execution of FDA 2253 reporting submissions, while also serving as Amgen's Digital Asset Management (DAM) librarian. In addition, this role will provide comprehensive administrative support to Operations staff throughout project lifecycles such as label changes. As a cross-functional position, you will collaborate closely with Regulatory Operations, engage with marketing teams as well as creative agencies to drive key commercial objectives. A strong proficiency in graphic design and video editing software-such as Adobe Creative Suite, Premiere Pro, and After Effects-is critical for success in this role. Additionally, proficiency with Veeva Promomats is highly preferred.
**Roles and Responsibilities:**
+ Conduct quality assurance reviews and process the daily release of FDA Form 2253 reportable submissions for promotional materials referencing marketed products.
+ Evaluate creative file submissions and system metadata of marketing materials, ensuring completeness, accuracy, and compliance with licensing requirements.
+ Collaborate with creative agencies and marketing teams to oversee the renegotiation, renewal and collection of usage rights for marketing materials.
+ Leverage company subscriptions to provide art procurement services in support of Amgen's marketing initiatives.
+ Retrieve, validate, and distribute digital asset packages to agencies and marketing teams, utilizing Amgen's various data repositories.
+ Facilitate and participate in stakeholder meetings to ensure adherence to Digital Asset Management (DAM) timelines and processes.
+ Maintain and manage records in Veeva Promomats, RIM and SharePoint; prior experience with SharePoint and Veeva Business Admin certification preferred.
+ Lead and facilitate Webex/MS Teams meetings, including agenda preparation and accurate documentation of meeting minutes.
+ Create infographics and presentation materials; perform technical editing and proofreading of process documentation.
**Required Knowledge and Skills:**
+ Veeva PromoMats and RIM experience.
+ Proficiency in Veeva PromoMats and RIM with hands-on experience navigating the platform to manage promotional and medical content.
+ Strong understanding of Veeva workflows, including initiating, reviewing, approving, and routing materials through the appropriate lifecycle stages.
+ Experience performing quality control (QC) checks on submitted materials to ensure compliance with US regulatory, legal, and brand standards.
+ Ability to update and maintain metadata accurately within Veeva PromoMats and RIM, ensuring consistency with naming conventions, taxonomy, and version control requirements.
+ Proficiency in Veeva digital asset management (DAM) systems and experience handling various file types, metadata, licensing agreements, and usage rights.
+ Familiarity with digital asset management (DAM) best practices, including asset tagging, archiving, and retrieval within Veeva, SharePoint, and BOX.
+ Knowledge of compliance and US FDA regulatory requirements for promotional materials in the pharmaceutical or life sciences industry.
+ Experience troubleshooting and resolving metadata or workflow issues, including collaboration with cross-functional teams (e.g., Regulatory, Marketing, or Creative Agencies).
+ Detail-oriented mindset with the ability to identify discrepancies and ensure data integrity across documents and metadata fields.
+ Comfortable working in a fast-paced, highly regulated environment, managing multiple tasks and priorities within tight deadlines.
+ Strong communication skills to effectively liaise with stakeholders and provide guidance on Amgen's Veeva PromoMats processes and best practices.
+ Experience in Veeva PromoMats to create Electronic Common Technical Documents (eCTD) compliance packages for US FDA 2253 submissions with a strong knowledge of US FDA eCTD publishing tools
+ Has knowledge of the US FDA guidance for submissions of promotional materials.
+ Strong knowledge of Adobe Creative Suite (Photoshop, Illustrator, InDesign) and other design tools.
+ Proficient in Microsoft Office Suite, including PowerPoint, Visio, Excel (with pivot tables), and Word.
+ Proven ability to manage multiple projects simultaneously while meeting deadlines and adhering to established processes.
+ MS Outlook inbox management, including organizational skills, creating email rules, and standard email templates.
+ Develop and maintain clear, structured process documents, SOPs, and workflow guides.
+ Design and run periodic and ad hoc reports using Veeva's reporting functionality to support leadership in the analysis and interpretation of performance data.
**Preferred Knowledge and Skills:**
+ Bachelor's degree in graphic design, visual arts, marketing, or a related creative field.
+ Minimum of +2 years of experience in marketing, pharmaceutical, or healthcare industries, with a strong understanding of regulatory requirements for promotional materials.
+ Veeva Business Admin certification.
+ Experience collaborating with creative agencies and cross-functional teams to facilitate the collection, transfer and distribution of marketing materials.
+ Excellent attention to detail and ability to conduct thorough quality control checks on creative files for promotional content.
+ Understanding FDA regulations and compliance requirements related to marketing materials and submissions.
+ Strong analytical and problem-solving skills to ensure accuracy in digital asset retrieval, troubleshooting of file issues, validation, and distribution.
+ Effective communication and stakeholder management skills to lead and participate in discussions regarding DAM timelines and creative file submission approvals.
**AIN working hours for this position:**
This position supports the Regulatory Promotion and Material Compliance activities serving Amgen's US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications.
**EQUAL OPPORTUNITY STATEMENT**
+ Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
+ We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
This advertiser has chosen not to accept applicants from your region.
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6
Regulatory Affairs Officer
Hyderabad, Andhra Pradesh
Weekday AI
Posted today
Job Viewed
Job Description
This role is for one of the Weekday's clients
Salary range: Rs - Rs (ie INR 3-8 LPA)
Min Experience: 3 years
Location: India, Hyderabad
JobType: full-time
Requirements
Key Responsibilities:
Drug Master Files (DMF):
- Prepare, compile, and review US DMFs (Type II), EU ASMFs, and other region-specific dossiers.
- Manage lifecycle activities such as updates, deficiency responses, and annual reports.
- Collaborate with internal teams to gather technical documents for submissions.
Regulatory Documentation & Submissions:
- Compile CTD/eCTD dossiers for global regulatory submissions (USFDA, EDQM, WHO, TGA, etc.).
- Ensure adherence to current international regulatory guidelines and standards.
- Maintain accurate records, document control systems, and submission archives.
Cross-Functional Collaboration:
- Coordinate with QA, QC, R&D, and Production teams for necessary documentation and technical inputs.
- Support preparation and review of product specifications, stability data, and Certificates of Analysis (COAs).
Audits & Inspections:
- Provide assistance during regulatory audits and inspections by international authorities and clients.
- Address regulatory queries and observations in a timely manner.
Regulatory Intelligence:
- Monitor and interpret updates in global regulatory guidelines (USFDA, EMA, ICH, etc.).
- Provide inputs on regulatory strategies, product classification, and compliance requirements.
Required Skills & Qualifications:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
- 3–7 years of experience in Regulatory Affairs, preferably in pharmaceuticals, nutraceuticals, or herbal formulations.
- Strong understanding of DMF/ASMF preparation and submission processes.
- Familiarity with global regulatory frameworks (USFDA, EMA, TGA, WHO, etc.).
- Excellent documentation, communication, and organizational skills.
- High attention to detail with the ability to manage deadlines effectively.
This advertiser has chosen not to accept applicants from your region.
7
Regulatory Affairs Assistant
Hyderabad, Andhra Pradesh
Gamut HR Solutions
Posted today
Job Viewed
Job Description
Company Overview
Gamut HR Solutions, headquartered in Hyderabad, is dedicated to connecting individuals with the right jobs. With a tight-knit team of 2-10 employees, our focus is on providing personalized employment solutions. Discover more about us at .
Job Overview
We are seeking a Mid-Level Regulatory Affairs Assistant to join our team full-time in Hyderabad. This role requires 4 to 6 years of experience in regulatory affairs, ideally in the healthcare or pharmaceutical sector. The candidate will play a vital part in navigating regulatory requirements and ensuring compliance for our projects.
Qualifications and Skills
- Proficiency in clinical trial documentation, ensuring that all protocols, reports, and submissions are accurately completed (Mandatory skill).
- Experience in regulatory submissions, including preparation, filing, and management for different regulatory bodies (Mandatory skill).
- Ability in regulatory strategic planning to develop comprehensive plans for meeting regulatory requirements (Mandatory skill).
- In-depth understanding of FDA regulations to ensure that all processes comply with necessary standards.
- Knowledge of EU MDR compliance, ensuring adherence to European Medical Device Regulation standards.
- Familiarity with GxP standards to assure the quality and integrity of processes and products.
- Experience in quality management systems to oversee processes meeting both internal and external requirements.
- Understanding of labeling requirements to ensure product labels meet regulatory standards.
Roles and Responsibilities
- Assist in the preparation and submission of regulatory documents to appropriate regulatory bodies.
- Coordinate with cross-functional teams to gather necessary documentation for regulatory submissions.
- Monitor and track submissions and ensure all regulatory timelines are met.
- Maintain up-to-date knowledge of regulatory requirements and changes in the regulatory landscape.
- Provide support in the development of regulatory strategies and implementation plans.
- Liaise with internal departments to ensure regulatory compliance is maintained across all projects.
- Prepare and review technical documentation to ensure compliance with regulatory standards.
- Support internal and external audits by gathering necessary documents and evidence.
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8
Regulatory Affairs Specialist
Secunderabad, Andhra Pradesh
Tek Support
Posted 1 day ago
Job Viewed
Job Description
Job Title: Regulatory Affairs Specialist Med/Pharma (Female)
Location: Remote
Position Overview:
We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.
Key Responsibilities:
- Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
- Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
- Developed and maintained regulatory strategies to support new product development and lifecycle management.
- Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
- Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
- Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
- Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
- Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
- Managed regulatory documentation archives and maintained compliance records for audits and inspections.
This advertiser has chosen not to accept applicants from your region.
9