46 Regulatory Affairs Positions jobs in Hyderabad
Regulatory Affairs Manager (CMC)
Hyderabad, Andhra Pradesh
Amgen
Posted 4 days ago
Job Viewed
Job Description
The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities.
Key Activities
Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management.
Key Responsibilities Include:
+ Generate and execute of global and country-specific regulatory strategies
+ Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
+ Develop global dossiers for CMC content for initial submissions, variations and amendments
+ Support change management activities
+ Develop response strategy and respond to health authority questions
+ Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans
+ Liaise with local regulatory teams to align on filing strategy
+ Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system
+ Follow established department regulatory processes to ensure cross-product alignment
Knowledge and Skills
CMC- specific regulatory knowledge & experience
Education & Experience (Basic)
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 in manufacture, testing (QC/QA or clinical), or distribution
Regulatory CMC experience
Key Activities
Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management.
Key Responsibilities Include:
+ Generate and execute of global and country-specific regulatory strategies
+ Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
+ Develop global dossiers for CMC content for initial submissions, variations and amendments
+ Support change management activities
+ Develop response strategy and respond to health authority questions
+ Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans
+ Liaise with local regulatory teams to align on filing strategy
+ Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system
+ Follow established department regulatory processes to ensure cross-product alignment
Knowledge and Skills
CMC- specific regulatory knowledge & experience
Education & Experience (Basic)
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 in manufacture, testing (QC/QA or clinical), or distribution
Regulatory CMC experience
This advertiser has chosen not to accept applicants from your region.
0
Regulatory Affairs Manager (Site)
Hyderabad, Andhra Pradesh
Amgen
Posted 4 days ago
Job Viewed
Job Description
Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India. The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintains state and federal licenses for Amgen products across phases of development, modality, and countries.
The team member will be responsible for maintaining U.S. state and federal commercial product licenses and will collaborate with Global CMC, Site CMC, Device Regulatory, Operations, Quality, and Supply Chain teams on strategies and activities impacting licensed products.
**Roles & Responsibilities:**
Key responsibilities of the Regulatory Affairs Manager include:
+ Conducts periodic assessments of licenses / facilities andensures business practices comply with current regulations and statutes.
+ Evaluates new and existing regulations to maintain up-to-date compliance.
+ Communicatesrequirements to internal Amgen functional teams.
+ Obtains supplemental documentation from internal and external partners.
+ Prepares, reviews, and submits license applications and renewals.
+ Maintains all State Licensing documentation, submissions, and interactions with State Authorities.
+ Interfaceswith State Board of Pharmacy (BoP) and/or Department of Health (DoH).
+ Completes required annual notifications to U.S. FDA
+ Obtains DUNS and FEI numbers for new U.S. sites, as required
+ Processes Financial obligations relating to fee payment.
+ Identifies and implements process improvements for the state licensing process
+ Coaches and supports junior regulatory staff's career development
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The successful candidate will have the following qualifications:
**Basic Qualifications:**
+ Doctorate degree OR
+ Master's degree and 3 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
+ Bachelor's degree and 5 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
**Preferred Qualifications:**
+ Degree in Life Science discipline
+ Regulatory CMC specific knowledge & experience
+ Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
+ Working knowledge of US state and/or federal licensing requirements
**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**
The team member will be responsible for maintaining U.S. state and federal commercial product licenses and will collaborate with Global CMC, Site CMC, Device Regulatory, Operations, Quality, and Supply Chain teams on strategies and activities impacting licensed products.
**Roles & Responsibilities:**
Key responsibilities of the Regulatory Affairs Manager include:
+ Conducts periodic assessments of licenses / facilities andensures business practices comply with current regulations and statutes.
+ Evaluates new and existing regulations to maintain up-to-date compliance.
+ Communicatesrequirements to internal Amgen functional teams.
+ Obtains supplemental documentation from internal and external partners.
+ Prepares, reviews, and submits license applications and renewals.
+ Maintains all State Licensing documentation, submissions, and interactions with State Authorities.
+ Interfaceswith State Board of Pharmacy (BoP) and/or Department of Health (DoH).
+ Completes required annual notifications to U.S. FDA
+ Obtains DUNS and FEI numbers for new U.S. sites, as required
+ Processes Financial obligations relating to fee payment.
+ Identifies and implements process improvements for the state licensing process
+ Coaches and supports junior regulatory staff's career development
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The successful candidate will have the following qualifications:
**Basic Qualifications:**
+ Doctorate degree OR
+ Master's degree and 3 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
+ Bachelor's degree and 5 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
**Preferred Qualifications:**
+ Degree in Life Science discipline
+ Regulatory CMC specific knowledge & experience
+ Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
+ Working knowledge of US state and/or federal licensing requirements
**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**
This advertiser has chosen not to accept applicants from your region.
1
Global Regulatory Affairs Manager
Hyderabad, Andhra Pradesh
ArtiXio
Posted today
Job Viewed
Job Description
About the Role
We are looking for a Regulatory Affairs Lead/ Project Manager to join our dynamic team. The ideal candidate is a passionate regulatory professional with hands-on experience in preparing and submitting applications to Health Authorities in Asia, LATAM, or other international markets. This role requires strong leadership, high attention to detail, and the ability to thrive in an entrepreneurial environment.
Key Responsibilities
- Manage Clients' Regulatory Projects for Pharmaceuticals, Biologics, Medical Devices and other products in Global Markets
- Plan and Prepare Regulatory Project Plans/Submission Strategies
- Lead regulatory submissions and manage interactions with Health Authorities across multiple regions.
- Identify regulatory gaps, assess risks, and provide clear guidance to cross-functional teams.
- Work closely with Regional Regulatory Experts, Provide Directions, Identify Gaps and Provide Strategic Direction
- Act as the primary point of contact for clients, ensuring proactive and effective communication.
- Drive project planning, execution, and monitoring to ensure timely and compliant delivery.
- Collaborate with business development teams to support proposals and regulatory strategy discussions.
- Mentor and guide junior team members, fostering a culture of excellence and accountability.
Qualifications
- 4–7 years of experience in regulatory affairs and project management within the pharmaceutical, biotech, or medical device sectors.
- Deep Understanding of Client Strategic Requirements against Global Regulatory and Documentation Requirements
- Proven track record of preparing and submitting applications to regional/global Health Authorities.
- Strong client-facing and stakeholder management skills.
- Entrepreneurial mindset: self-starter, problem-solver, and capable of driving initiatives independently.
- Excellent organizational, communication, and leadership skills.
Why Join Us
- Opportunity to work on diverse global projects across multiple markets.
- Collaborative, growth-oriented, and innovative work culture.
- A platform to take ownership, lead client interactions, and contribute to global healthcare access.
This advertiser has chosen not to accept applicants from your region.
2
Medical Device Regulatory Affairs Manager
Hyderabad, Andhra Pradesh
ArtiXio
Posted today
Job Viewed
Job Description
About the Role
We are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO , and other global regulatory agencies. This role requires leadership, ownership, and the ability to guide cross-functional teams through complex regulatory pathways.
Key Responsibilities
- Lead the preparation, submission, and management of medical device applications (US FDA 510k, CE Marking, MDSAP, CDSCO, and other markets).
- Ensure compliance with regulatory standards including ISO 13485, 21 CFR 820 , and other applicable regulations.
- Act as the primary contact for Health Authorities, managing queries and responses effectively.
- Oversee regulatory strategy, project planning, and execution for medical device submissions.
- Provide guidance on Quality Management Systems (QMS) and support audits/inspections.
- Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Clinical, Commercial) to align regulatory requirements with business objectives.
- Take ownership of projects, demonstrating leadership and accountability in delivery.
Qualifications
- 4–6 years of experience in medical device regulatory affairs .
- Proven track record with submissions to FDA (510k), CE Marking, CDSCO, and other agencies .
- Strong knowledge of ISO 13485, 21 CFR 820, QMS practices, and international medical device regulations .
- Experience in responding to Health Authority queries and managing regulatory communications.
- Excellent project management, organizational, and leadership skills.
- Ability to work independently, take ownership, and drive results.
Why Join Us
- Opportunity to lead regulatory projects across global markets.
- Work in a dynamic, entrepreneurial, and collaborative environment.
- Be at the forefront of advancing compliance and patient safety in medical devices.
- Apply now via LinkedIn or connect with us to explore this opportunity
This advertiser has chosen not to accept applicants from your region.
3
Compliance and Regulatory Affairs Manager
Hyderabad, Andhra Pradesh
Skyroot Aerospace
Posted today
Job Viewed
Job Description
Job Summary:
The Manager - Compliance will be responsible for ensuring full compliance with Special Economic Zone (SEZ) rules, Factory and Labour laws, Vendor & Third-Party compliance, Facility compliance, and other statutory requirements applicable to the unit. The role involves coordinating with SEZ authorities, government officials, external audit teams, and internal stakeholders to ensure seamless compliance management.
Key Responsibilities:
SEZ Compliance
- Ensure adherence to SEZ Act, 2005 and SEZ Rules, 2006 for all operations within the SEZ.
- Manage SEZ online portal activities (Softex Forms, Bond-cum-Legal Undertaking, statutory filings).
- Handle documentation for material movements (inward, outward, subcontracting, job work, re-imports, exports).
- Prepare and submit Monthly, Quarterly, and Annual SEZ reports.
- Liaise with SEZ office, Customs, and SEZ authorities for approvals, permissions, and audits.
Factories & Labour Compliance
- Ensure compliance with Factories Act, 1948, Shops & Establishments Act, and other applicable labour laws (PF, ESI, CLRA, Gratuity, Maternity Benefits, etc.).
- Coordinate with the Labour Department & Factory Inspectorate for licenses, inspections, and statutory submissions.
- Maintain statutory registers and compliance records related to labour and factory operations.
- Monitor safety regulations, working hours, overtime, and occupational health norms.
Vendor & Third-Party Compliance
- Ensure vendors and contractors comply with PF, ESI, GST, SEZ norms, and labour obligations.
- Manage compliance for third-party service providers (security, housekeeping, canteen, contractors).
- Conduct periodic vendor audits and compliance checks.
Facility Compliance
- Ensure compliance with fire safety, pollution control, health & safety regulations, and environmental standards.
- Track and renew facility-related licenses, approvals, and NOCs.
- Coordinate with facility management teams to ensure compliance readiness.
Liaison & Audit Support
- Liaise with government officials (SEZ, Customs, Labour, Factory, Fire, Pollution Control Board).
- Support external & internal auditors, statutory auditors, and regulatory inspections.
- Handle compliance queries, audits, and investigations with accuracy and transparency.
General Compliance & Coordination
- Maintain and update all statutory registers, stock registers, and compliance records.
- Monitor validity and renewal of bank guarantees, SEZ LOAs, LUTs, licenses, and authorizations.
- Liaise with internal teams (Finance, HR, Logistics, Operations) for smooth compliance execution.
- Stay updated with amendments, circulars, and notifications in SEZ, Factory, Labour, and Facility laws, ensuring implementation.
- Manage all facility-related insurance requirements, ensuring timely renewals and sourcing of new insurance coverage in line with organizational needs.
Qualifications & Skills:
- Graduate/Postgraduate in Commerce, Law, Business Administration, or related field.
- 6+ years of experience in SEZ, Factory, Labour, Vendor & Facility compliance (preferably in a manufacturing/aerospace/engineering SEZ unit).
- Strong knowledge of SEZ Rules, Factories Act, Labour Laws, GST exemptions, Customs Act.
- Proficiency in MS Office and SEZ Online portal.
- Strong documentation, analytical, and coordination skills.
- Excellent communication and liaison abilities with authorities, auditors, vendors, and internal teams.
- Ability to manage multiple compliance areas under strict deadlines.
This advertiser has chosen not to accept applicants from your region.
4
Regulatory Affairs Senior Manager (CMC)
Hyderabad, Andhra Pradesh
Amgen
Posted 4 days ago
Job Viewed
Job Description
The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities.
Key Activities
Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management.
Key Responsibilities Include:
+ Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development,
+ Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally
+ Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation
+ Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff
+ Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
+ Develop response strategy and respond to health authority questions
+ Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans
+ Liaise with local regulatory teams to align on filing strategy
+ Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system
+ Follow established department regulatory processes to ensure cross-product alignment
Knowledge and Skills
Regulatory CMC- specific regulatory knowledge & experience
Staff management and development
Education & Experience (Basic)
Doctorate degree
OR
Master's degree and 3 years of directly related experience
OR
Bachelor's degree and 5 years of directly related experience
OR
Associate's degree and10 years of directly related experience
Experience in manufacture, testing (QC/QA or clinical), or distribution
Regulatory CMC experience
**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.
Key Activities
Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management.
Key Responsibilities Include:
+ Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development,
+ Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally
+ Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation
+ Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff
+ Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
+ Develop response strategy and respond to health authority questions
+ Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans
+ Liaise with local regulatory teams to align on filing strategy
+ Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system
+ Follow established department regulatory processes to ensure cross-product alignment
Knowledge and Skills
Regulatory CMC- specific regulatory knowledge & experience
Staff management and development
Education & Experience (Basic)
Doctorate degree
OR
Master's degree and 3 years of directly related experience
OR
Bachelor's degree and 5 years of directly related experience
OR
Associate's degree and10 years of directly related experience
Experience in manufacture, testing (QC/QA or clinical), or distribution
Regulatory CMC experience
**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
Regulatory Affairs Lead, Project Manager
Hyderabad, Andhra Pradesh
ArtiXio
Posted today
Job Viewed
Job Description
About the Role
We are looking for a Regulatory Affairs Lead/ Project Manager to join our dynamic team. The ideal candidate is a passionate regulatory professional with hands-on experience in preparing and submitting applications to Health Authorities in Asia, LATAM, or other international markets. This role requires strong leadership, high attention to detail, and the ability to thrive in an entrepreneurial environment.
Key Responsibilities
- Manage Clients' Regulatory Projects for Pharmaceuticals, Biologics, Medical Devices and other products in Global Markets
- Plan and Prepare Regulatory Project Plans/Submission Strategies
- Lead regulatory submissions and manage interactions with Health Authorities across multiple regions.
- Identify regulatory gaps, assess risks, and provide clear guidance to cross-functional teams.
- Work closely with Regional Regulatory Experts, Provide Directions, Identify Gaps and Provide Strategic Direction
- Act as the primary point of contact for clients, ensuring proactive and effective communication.
- Drive project planning, execution, and monitoring to ensure timely and compliant delivery.
- Collaborate with business development teams to support proposals and regulatory strategy discussions.
- Mentor and guide junior team members, fostering a culture of excellence and accountability.
Qualifications
- 4–7 years of experience in regulatory affairs and project management within the pharmaceutical, biotech, or medical device sectors.
- Deep Understanding of Client Strategic Requirements against Global Regulatory and Documentation Requirements
- Proven track record of preparing and submitting applications to regional/global Health Authorities.
- Strong client-facing and stakeholder management skills.
- Entrepreneurial mindset: self-starter, problem-solver, and capable of driving initiatives independently.
- Excellent organizational, communication, and leadership skills.
Why Join Us
- Opportunity to work on diverse global projects across multiple markets.
- Collaborative, growth-oriented, and innovative work culture.
- A platform to take ownership, lead client interactions, and contribute to global healthcare access.
This advertiser has chosen not to accept applicants from your region.
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6
Regulatory Affairs Lead, Project Manager
Hyderabad, Andhra Pradesh
ArtiXio
Posted 1 day ago
Job Viewed
Job Description
About the Role
We are looking for a Regulatory Affairs Lead/ Project Manager to join our dynamic team. The ideal candidate is a passionate regulatory professional with hands-on experience in preparing and submitting applications to Health Authorities in Asia, LATAM, or other international markets. This role requires strong leadership, high attention to detail, and the ability to thrive in an entrepreneurial environment.
Key Responsibilities
- Manage Clients' Regulatory Projects for Pharmaceuticals, Biologics, Medical Devices and other products in Global Markets
- Plan and Prepare Regulatory Project Plans/Submission Strategies
- Lead regulatory submissions and manage interactions with Health Authorities across multiple regions.
- Identify regulatory gaps, assess risks, and provide clear guidance to cross-functional teams.
- Work closely with Regional Regulatory Experts, Provide Directions, Identify Gaps and Provide Strategic Direction
- Act as the primary point of contact for clients, ensuring proactive and effective communication.
- Drive project planning, execution, and monitoring to ensure timely and compliant delivery.
- Collaborate with business development teams to support proposals and regulatory strategy discussions.
- Mentor and guide junior team members, fostering a culture of excellence and accountability.
Qualifications
- 4–7 years of experience in regulatory affairs and project management within the pharmaceutical, biotech, or medical device sectors.
- Deep Understanding of Client Strategic Requirements against Global Regulatory and Documentation Requirements
- Proven track record of preparing and submitting applications to regional/global Health Authorities.
- Strong client-facing and stakeholder management skills.
- Entrepreneurial mindset: self-starter, problem-solver, and capable of driving initiatives independently.
- Excellent organizational, communication, and leadership skills.
Why Join Us
- Opportunity to work on diverse global projects across multiple markets.
- Collaborative, growth-oriented, and innovative work culture.
- A platform to take ownership, lead client interactions, and contribute to global healthcare access.
We are looking for a Regulatory Affairs Lead/ Project Manager to join our dynamic team. The ideal candidate is a passionate regulatory professional with hands-on experience in preparing and submitting applications to Health Authorities in Asia, LATAM, or other international markets. This role requires strong leadership, high attention to detail, and the ability to thrive in an entrepreneurial environment.
Key Responsibilities
- Manage Clients' Regulatory Projects for Pharmaceuticals, Biologics, Medical Devices and other products in Global Markets
- Plan and Prepare Regulatory Project Plans/Submission Strategies
- Lead regulatory submissions and manage interactions with Health Authorities across multiple regions.
- Identify regulatory gaps, assess risks, and provide clear guidance to cross-functional teams.
- Work closely with Regional Regulatory Experts, Provide Directions, Identify Gaps and Provide Strategic Direction
- Act as the primary point of contact for clients, ensuring proactive and effective communication.
- Drive project planning, execution, and monitoring to ensure timely and compliant delivery.
- Collaborate with business development teams to support proposals and regulatory strategy discussions.
- Mentor and guide junior team members, fostering a culture of excellence and accountability.
Qualifications
- 4–7 years of experience in regulatory affairs and project management within the pharmaceutical, biotech, or medical device sectors.
- Deep Understanding of Client Strategic Requirements against Global Regulatory and Documentation Requirements
- Proven track record of preparing and submitting applications to regional/global Health Authorities.
- Strong client-facing and stakeholder management skills.
- Entrepreneurial mindset: self-starter, problem-solver, and capable of driving initiatives independently.
- Excellent organizational, communication, and leadership skills.
Why Join Us
- Opportunity to work on diverse global projects across multiple markets.
- Collaborative, growth-oriented, and innovative work culture.
- A platform to take ownership, lead client interactions, and contribute to global healthcare access.
This advertiser has chosen not to accept applicants from your region.
7
Regulatory affairs lead, project manager
Hyderabad, Andhra Pradesh
ArtiXio
Posted 5 days ago
Job Viewed
Job Description
About the Role
We are looking for a Regulatory Affairs Lead/ Project Manager to join our dynamic team. The ideal candidate is a passionate regulatory professional with hands-on experience in preparing and submitting applications to Health Authorities in Asia, LATAM, or other international markets. This role requires strong leadership, high attention to detail, and the ability to thrive in an entrepreneurial environment.
Key Responsibilities
Manage Clients' Regulatory Projects for Pharmaceuticals, Biologics, Medical Devices and other products in Global Markets
Plan and Prepare Regulatory Project Plans/Submission Strategies
Lead regulatory submissions and manage interactions with Health Authorities across multiple regions.
Identify regulatory gaps, assess risks, and provide clear guidance to cross-functional teams.
Work closely with Regional Regulatory Experts, Provide Directions, Identify Gaps and Provide Strategic Direction
Act as the primary point of contact for clients, ensuring proactive and effective communication.
Drive project planning, execution, and monitoring to ensure timely and compliant delivery.
Collaborate with business development teams to support proposals and regulatory strategy discussions.
Mentor and guide junior team members, fostering a culture of excellence and accountability.
Qualifications
4–7 years of experience in regulatory affairs and project management within the pharmaceutical, biotech, or medical device sectors.
Deep Understanding of Client Strategic Requirements against Global Regulatory and Documentation Requirements
Proven track record of preparing and submitting applications to regional/global Health Authorities.
Strong client-facing and stakeholder management skills.
Entrepreneurial mindset: self-starter, problem-solver, and capable of driving initiatives independently.
Excellent organizational, communication, and leadership skills.
Why Join Us
Opportunity to work on diverse global projects across multiple markets.
Collaborative, growth-oriented, and innovative work culture.
A platform to take ownership, lead client interactions, and contribute to global healthcare access.
We are looking for a Regulatory Affairs Lead/ Project Manager to join our dynamic team. The ideal candidate is a passionate regulatory professional with hands-on experience in preparing and submitting applications to Health Authorities in Asia, LATAM, or other international markets. This role requires strong leadership, high attention to detail, and the ability to thrive in an entrepreneurial environment.
Key Responsibilities
Manage Clients' Regulatory Projects for Pharmaceuticals, Biologics, Medical Devices and other products in Global Markets
Plan and Prepare Regulatory Project Plans/Submission Strategies
Lead regulatory submissions and manage interactions with Health Authorities across multiple regions.
Identify regulatory gaps, assess risks, and provide clear guidance to cross-functional teams.
Work closely with Regional Regulatory Experts, Provide Directions, Identify Gaps and Provide Strategic Direction
Act as the primary point of contact for clients, ensuring proactive and effective communication.
Drive project planning, execution, and monitoring to ensure timely and compliant delivery.
Collaborate with business development teams to support proposals and regulatory strategy discussions.
Mentor and guide junior team members, fostering a culture of excellence and accountability.
Qualifications
4–7 years of experience in regulatory affairs and project management within the pharmaceutical, biotech, or medical device sectors.
Deep Understanding of Client Strategic Requirements against Global Regulatory and Documentation Requirements
Proven track record of preparing and submitting applications to regional/global Health Authorities.
Strong client-facing and stakeholder management skills.
Entrepreneurial mindset: self-starter, problem-solver, and capable of driving initiatives independently.
Excellent organizational, communication, and leadership skills.
Why Join Us
Opportunity to work on diverse global projects across multiple markets.
Collaborative, growth-oriented, and innovative work culture.
A platform to take ownership, lead client interactions, and contribute to global healthcare access.
This advertiser has chosen not to accept applicants from your region.
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Regulatory Affairs Lead, Project Manager
Hyderabad, Andhra Pradesh
ArtiXio
Posted 25 days ago
Job Viewed
Job Description
About the Role
We are looking for a Regulatory Affairs Lead/ Project Manager to join our dynamic team. The ideal candidate is a passionate regulatory professional with hands-on experience in preparing and submitting applications to Health Authorities in Asia, LATAM, or other international markets. This role requires strong leadership, high attention to detail, and the ability to thrive in an entrepreneurial environment.
Key Responsibilities
- Manage Clients' Regulatory Projects for Pharmaceuticals, Biologics, Medical Devices and other products in Global Markets
- Plan and Prepare Regulatory Project Plans/Submission Strategies
- Lead regulatory submissions and manage interactions with Health Authorities across multiple regions.
- Identify regulatory gaps, assess risks, and provide clear guidance to cross-functional teams.
- Work closely with Regional Regulatory Experts, Provide Directions, Identify Gaps and Provide Strategic Direction
- Act as the primary point of contact for clients, ensuring proactive and effective communication.
- Drive project planning, execution, and monitoring to ensure timely and compliant delivery.
- Collaborate with business development teams to support proposals and regulatory strategy discussions.
- Mentor and guide junior team members, fostering a culture of excellence and accountability.
Qualifications
- 4–7 years of experience in regulatory affairs and project management within the pharmaceutical, biotech, or medical device sectors.
- Deep Understanding of Client Strategic Requirements against Global Regulatory and Documentation Requirements
- Proven track record of preparing and submitting applications to regional/global Health Authorities.
- Strong client-facing and stakeholder management skills.
- Entrepreneurial mindset: self-starter, problem-solver, and capable of driving initiatives independently.
- Excellent organizational, communication, and leadership skills.
Why Join Us
- Opportunity to work on diverse global projects across multiple markets.
- Collaborative, growth-oriented, and innovative work culture.
- A platform to take ownership, lead client interactions, and contribute to global healthcare access.
This advertiser has chosen not to accept applicants from your region.
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