510 Pharmaceutical Safety jobs in India
Regulatory Affairs
Posted today
Job Viewed
Job Description
- Optional NFP tax free benefit of $15,900 per annum
- Located at Camperdown close to public transport
- Fitness passport for you and your family
Chris O’Brien Lifehouse is an internationally recognised independent, not-for-profit cancer hospital leading the way in delivering patient-centred cancer care. We seek passionate, caring, and dedicated staff who align with our Founder’s vision of creating a collaborative environment in which, respect, discovery, empowerment, and nurture, thrive in the interests of our patients.
About the role
The role of Regulatory affairs is to coordinate the regulatory affairs relating to the clinical trials performed at Chris O’Brien Lifehouse within the Clinical trials team in a timely manner with accuracy & efficiency. This position is part of a small team that works closely with a multi-functional team consisting of doctors, pharmacists, clinical study coordinators, data managers, internal start-up specialists, study sponsor teams and clinical research associates to assist in conducting early phase clinical research trials.
Essential Criteria
- Ability to work autonomously & as a team member that is inclusive, approachable & supportive
- Previous Regulatory Affairs experience
- Good negotiating & communications skills with the ability to challenge, if applicable
- Demonstrated high level of interpersonal skills, including verbal and written communication
- Ability to manage multiple projects
- Ability to establish & maintain effective working relationships with colleagues, managers & clients
- Problem solving with a strong focus on accuracy
- Excellent planning & organisational skills to prioritise tasks & meet deadlines
- Attention to detail and proactive nature
- Evidence of immunisations to comply with the NSW Health Occupational Assessment, Screening & Vaccination against Specified Infectious Diseases Policy for a Category B position
- Previous budget & contract negotiation experience - desirable
- Knowledge of Clinical trials and or Good Clinical Practice (GCP) – desirable
Benefits
- Access to e-Learning programs
- Social and wellbeing events
- CBHS Corporate Health
- Workplace banking benefits
- Access EAP
Culture
We are committed to providing a working environment where everyone is valued, respected, and supported to progress. Our priority is to ensure culture, policies, and processes are truly inclusive and that no one is disadvantaged because of their Indigenous identity, gender, culture, disability, LGBTIQA+ identities, family and caring responsibilities, age, or religion.
We encourage everyone who meets the selection criteria and shares Chris O`Brien Lifehouse values to apply.
Back to job listing
Regulatory Affairs
Posted today
Job Viewed
Job Description
Company Overview
JD Lifesciences, operating under J D HEALTHCARE LIMITED, i s a fast-growing healthcare company specializing in biomedical equipment and life-saving medical solutions. We are committed to delivering reliable, innovative and quality products to hospitals, clinics and healthcare institutions across the country.
Job Overview
We are seeking a detail-oriented and experienced professional to join our team as a Regulatory Affairs Specialist, located in Mumbai Suburban. This is a mid-level, full-time position requiring 4 to 6 years of experience. The selected candidate will play a crucial role in managing regulatory compliance and submissions in accordance with international standards and guidelines.
Qualifications and Skills
- Proven experience with regulatory submissions and a deep understanding of regulatory processes in the medical device industry.
- In-depth knowledge of FDA regulations and how they apply to product development and compliance in the healthcare sector.
- Experience with Quality Management Systems, ensuring that company processes align with regulatory and quality standards.
- Familiarity with ICH guidelines, which guide pharmaceutical product dossier creation and submission.
- Proficiency in CTD/eCTD compilation for documentation and electronic submissions of regulatory filings.
- Ability to develop comprehensive regulatory strategies that align with business goals and compliance requirements.
- Understanding of EU Medical Device Regulations (MDR) and their implications for international product submissions.
- Skilled in ensuring labeling compliance, making sure product labels meet all necessary regulatory standards.
Roles and Responsibilities
- Prepare, review and submit regulatory documents to ensure timely and efficient product approvals.
- Conduct regulatory assessments to determine applicable regulatory requirements for new products.
- Develop and implement regulatory strategies to support product development and compliance initiatives.
- Ensure product labeling meets regulatory requirements and guidelines in all relevant markets.
- Monitor changes in regulations and guidelines and communicate impacts to internal stakeholders.
- Collaborate with cross-functional teams, providing regulatory guidance and support as needed.
- Maintain regulatory files and databases to ensure all documentation is up-to-date and compliant.
- Liaise with regulatory authorities as needed to facilitate product approvals and resolve compliance issues.
Regulatory Affairs
Posted today
Job Viewed
Job Description
**Vivanza Biosciences Limited** is seeking a highly motivated and detail-oriented professional to join our team as a **Regulatory Affairs Executive** in Ahmedabad, Gujarat. This role is ideal for an individual with foundational experience in the pharmaceutical industry who is keen to grow their career in regulatory compliance and submissions for global markets.
| Position | Regulatory Affairs Executive |
| **Experience** | 6 months to 1 year |
| **Location** | Ahmedabad, Gujarat |
| **Qualification** | B.Pharm/M.Pharm |
Key Responsibilities
As a Regulatory Affairs Executive, you will primarily be responsible for supporting the regulatory filing process and maintaining product compliance in various international markets, with a focus on emerging markets.
* **Documentation and Dossier Support:**
* Assist in the preparation and compilation of drug product dossiers, primarily in **ACTD/CTD formats**, for submission to regulatory authorities in African, LATAM, CIS Countries, and other emerging markets.
* Support the compilation of essential regulatory documents such as **Certificates of Analysis (COA)**, **Manufacturing Formula Records (MFR)**, **Process Validation (PV)**, and **Stability Data**.
* Ensure all documents are accurate, complete, and compliant with country-specific regulatory guidelines.
* **Cross-Functional Coordination:**
* Liaise and coordinate effectively with internal departments, including **Formulation & Development (F&D)**, **Quality Assurance (QA)**, **Quality Control (QC)**, and **Production**, to gather necessary technical and quality documentation.
* Coordinate with the Artwork department for review and approval of product labeling and packaging materials to ensure regulatory compliance.
* **Compliance and Maintenance:**
* Assist in the review of technical documentation (**CMC review**) for regulatory filings.
* Maintain and track records of regulatory submissions, approvals, and correspondences with health authorities.
* Support the team in responding to regulatory queries and deficiencies in a timely manner.
* **Regulatory Intelligence:**
* Conduct basic research on updated regulatory guidelines and requirements for target markets.
***
# Required Qualifications and Skills
* **Education:** Bachelor of Pharmacy (**B.Pharm**) or Master of Pharmacy (**M.Pharm**) from a recognized university.
* **Experience:** 6 months to 1 year of hands-on experience in Regulatory Affairs within the pharmaceutical industry.
* **Technical Skills:**
* Basic knowledge of **CTD/ACTD** structure and regulatory documentation.
* Familiarity with regulatory requirements for international/emerging markets is a plus.
* Proficiency in **MS Office** (Word, Excel, PowerPoint) and electronic document management systems.
* **Soft Skills:**
* Excellent **attention to detail** and organizational skills.
* Strong written and verbal **communication skills**.
* Ability to work effectively in a team and coordinate with various departments.
* High degree of professionalism and a proactive approach to work.
***
Why Vivanza Biosciences Limited?
Join a growing pharmaceutical company dedicated to providing high-quality, affordable medicines globally. At Vivanza Biosciences, you will have the opportunity to:
* Gain hands-on experience in a critical function of the pharmaceutical industry.
* Work on regulatory submissions for a diverse portfolio and global markets.
* Grow your career in a dynamic and supportive environment.
Regulatory Affairs
Posted 19 days ago
Job Viewed
Job Description
Company Overview
JD Lifesciences, operating under J D HEALTHCARE LIMITED, i s a fast-growing healthcare company specializing in biomedical equipment and life-saving medical solutions. We are committed to delivering reliable, innovative and quality products to hospitals, clinics and healthcare institutions across the country.
Job Overview
We are seeking a detail-oriented and experienced professional to join our team as a Regulatory Affairs Specialist, located in Mumbai Suburban. This is a mid-level, full-time position requiring 4 to 6 years of experience. The selected candidate will play a crucial role in managing regulatory compliance and submissions in accordance with international standards and guidelines.
Qualifications and Skills
- Proven experience with regulatory submissions and a deep understanding of regulatory processes in the medical device industry.
- In-depth knowledge of FDA regulations and how they apply to product development and compliance in the healthcare sector.
- Experience with Quality Management Systems, ensuring that company processes align with regulatory and quality standards.
- Familiarity with ICH guidelines, which guide pharmaceutical product dossier creation and submission.
- Proficiency in CTD/eCTD compilation for documentation and electronic submissions of regulatory filings.
- Ability to develop comprehensive regulatory strategies that align with business goals and compliance requirements.
- Understanding of EU Medical Device Regulations (MDR) and their implications for international product submissions.
- Skilled in ensuring labeling compliance, making sure product labels meet all necessary regulatory standards.
Roles and Responsibilities
- Prepare, review and submit regulatory documents to ensure timely and efficient product approvals.
- Conduct regulatory assessments to determine applicable regulatory requirements for new products.
- Develop and implement regulatory strategies to support product development and compliance initiatives.
- Ensure product labeling meets regulatory requirements and guidelines in all relevant markets.
- Monitor changes in regulations and guidelines and communicate impacts to internal stakeholders.
- Collaborate with cross-functional teams, providing regulatory guidance and support as needed.
- Maintain regulatory files and databases to ensure all documentation is up-to-date and compliant.
- Liaise with regulatory authorities as needed to facilitate product approvals and resolve compliance issues.
Clinical Safety Analyst-Reputed Clinical industry-Chennai, Tamil Nadu, India -4 Lakhs-Sonali
Posted today
Job Viewed
Job Description
JOB DETAILS
1.approval of the Clinical Risk Management Plan, to confirm that the plan is appropriate and achievable in the context of Meds Companion
2.ensuring that clinical risk management activities are completed in accordance with the Clinical Risk Management Plan
3.reviewing and approving of safety documentation
4.reviewing of evidence in the Clinical Risk Management File,for completeness and support of the Clinical Safety Case Report
5.providing recommendation to Management regarding whether Meds Companion is safe to release
6.raising any unacceptable safety risks with Management be a suitably-qualified and experienced healthcare professional
7.hold a current registration with an appropriate professional body relevant to their training and experience
8.be knowledgeable in risk management and its application to clinical domains
9.have an understanding in the principles of risk and safety as applied to Health IT systems.
10.able to comprehend the nature of Meds Companion being developed, the human factors, and their contribution and control in the context of patient harm
FUNCTIONAL AREA
Clinical Safety, Safety Officer, Medical Safety Officer, Jobs for Medical Staffs, Jobs for Medical Safety Officer, Clinical Industry Jobs, Jobs for Clinical Safety Analyst, Jobs for Medical Safety Analyst, Jobs for Healthcare Staffs, Healthcare Industry Jobs, Jobs for Clinical Safety Analyst in Chennai, Jobs for Clinical Safety Analyst in Tamil Nadu, Clinical Recruitment Agencies in Chennai, Clinical Placement Agencies in Chennai, Clinical Placement Consultants in Chennai, Clinical Recruitment Consultants in Chennai, Medical Recruitment agencies in Chennai, Clinical Jobs Placement Agency in Chennai, Clinical Recruitment Agencies in India, Clinical Placement Agencies in India, Clinical Placement Consultants in India, Clinical Recruitment Consultants in India, Medical Recruitment agencies in India, Clinical Jobs Placement Agency in India.
Apply Now
Manager, Clinical and Safety Analytics
Posted today
Job Viewed
Job Description
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
This position is responsible for enhancing and developing a framework related to data analytics reporting utilizing metrics collected within the Worldwide Patient Safety & PV CoE Analytics function. The Analyst will enable analytical use of the compliance data that provides insights related to productivity, efficiency, and quality to facilitate informed decision making for BMS REMS & Clinical Analytics.
**Position Responsibilities**
● Responsible for ensuring compliance with regulatory requirements, enhancing drug safety and regulatory adherence with qualitative and quantitative research projects through collaboration with data trends from cross-functional teams (Regulatory, Medical & Clinical Safety, Commercial, Brand Marketing, etc.)
● Maintain and develop programming, reporting and analytics applications in BMS environments such as Spotfire, Tableau, Excel.
● Leverage internal data systems and tools to efficiently maintain data visualization, communications and reporting processes to minimize manual data retrieving
● Utilize data analysis tools to aggregate and analyze data to make actional recommendations and answer key business questions.
● Develop, Run, and maintain reports regarding activities, outcomes, and trends and be prepared to deliver presentations to management team on a regular and ad-hoc basis
● Continually remain apprised of the constantly changing landscape of the healthcare industry and any impacts it may have to our REMS programs and reporting mechanisms
● Obtain a deep understanding of the prescriber and pharmacy operating environments through View Job Posting Details vendor and consulting interactions, stakeholder discussions, conference attendance, BMS events etc.
● Analyze key stakeholder complaints, address rapidly, and discuss with applicable functional leads to collaborate and propose impactful and realistic solutions
● Interpret and contextualize analytical findings documented by the REMS Advisor team
● Develop, Run and maintain reports and studies regarding Real world data analytics and present the outcomes to the stakeholders.
**Other tasks**
● Provide scheduled and ad-hoc reports to the leadership team as required
● Supporting Audit Activities related to BMS REMS & Clinical programs.
**Key Competency Requirements**
● Strong PowerPoint and Excel Skills
● Programming languages like SAS, SQL or Python etc.
● Strong knowledge and expertise in Tableau & and familiarity with Spotfire
● Databases (Salesforce, Postgres, Oracle, SharePoint List etc.)
● Ability to organize/curate data and see big picture from scattered pieces of information
● Analytical and strategic thinking skills required
● Familiarity and ability to navigate with Clinical and Real-world data
● Knowledge of Validation processes and associated documentation
● Excellent verbal, writing, presentation and project management skills
● Strong strategic orientation with ability to translate into operational priorities and plans
● Demonstrated ability to work on multiple projects
● Strong willingness to collaborate with cross-functional partners, flexible team member with positive attitude, friendly demeanor, ability to prioritize projects and balance competing priorities
● Confidentiality and integrity are required
● Strong work ethic a must
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :07:14.624 UTC
**Location:** Hyderabad-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Manager, Clinical and Safety Analytics
Posted today
Job Viewed
Job Description
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
This position is responsible for enhancing and developing a framework related to data analytics reporting utilizing metrics collected within the Worldwide Patient Safety & PV CoE Analytics function. The Analyst will enable analytical use of the compliance data that provides insights related to productivity, efficiency, and quality to facilitate informed decision making for BMS REMS & Clinical Analytics.
Position Responsibilities
● Responsible for ensuring compliance with regulatory requirements, enhancing drug safety and regulatory adherence with qualitative and quantitative research projects through collaboration with data trends from cross-functional teams (Regulatory, Medical & Clinical Safety, Commercial, Brand Marketing, etc.)
● Maintain and develop programming, reporting and analytics applications in BMS environments such as Spotfire, Tableau, Excel.
● Leverage internal data systems and tools to efficiently maintain data visualization, communications and reporting processes to minimize manual data retrieving
● Utilize data analysis tools to aggregate and analyze data to make actional recommendations and answer key business questions.
● Develop, Run, and maintain reports regarding activities, outcomes, and trends and be prepared to deliver presentations to management team on a regular and ad-hoc basis
● Continually remain apprised of the constantly changing landscape of the healthcare industry and any impacts it may have to our REMS programs and reporting mechanisms
● Obtain a deep understanding of the prescriber and pharmacy operating environments through View Job Posting Details vendor and consulting interactions, stakeholder discussions, conference attendance, BMS events etc.
● Analyze key stakeholder complaints, address rapidly, and discuss with applicable functional leads to collaborate and propose impactful and realistic solutions
● Interpret and contextualize analytical findings documented by the REMS Advisor team
● Develop, Run and maintain reports and studies regarding Real world data analytics and present the outcomes to the stakeholders.
Other tasks
● Provide scheduled and ad-hoc reports to the leadership team as required
● Supporting Audit Activities related to BMS REMS & Clinical programs.
Key Competency Requirements
● Strong PowerPoint and Excel Skills
● Programming languages like SAS, SQL or Python etc.
● Strong knowledge and expertise in Tableau & and familiarity with Spotfire
● Databases (Salesforce, Postgres, Oracle, SharePoint List etc.)
● Ability to organize/curate data and see big picture from scattered pieces of information
● Analytical and strategic thinking skills required
● Familiarity and ability to navigate with Clinical and Real-world data
● Knowledge of Validation processes and associated documentation
● Excellent verbal, writing, presentation and project management skills
● Strong strategic orientation with ability to translate into operational priorities and plans
● Demonstrated ability to work on multiple projects
● Strong willingness to collaborate with cross-functional partners, flexible team member with positive attitude, friendly demeanor, ability to prioritize projects and balance competing priorities
● Confidentiality and integrity are required
● Strong work ethic a must
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Be The First To Know
About the latest Pharmaceutical safety Jobs in India !
Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
+ Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
+ Leads or compiles all materials required in submissions, license renewal and annual registrations.
+ Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
+ Monitors and improves tracking / control systems.
+ Keeps abreast of regulatory procedures and changes.
+ May direct interaction with regulatory agencies on defined matters.
+ Recommends strategies for earliest possible approvals of clinical trials applications.
**SPECIALIST CAREER STREAM:** Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
**DIFFERENTIATING FACTORS**
**Autonomy:** Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
**Organizational Impact:** Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.
**Innovation and Complexity:** Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
**Communication and Influence:** Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
**Leadership and Talent Management:** May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
**Required Knowledge and Experience:** Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 1 year of relevant experience.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic 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, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
Dir Regulatory Affairs
Posted today
Job Viewed
Job Description
Date: Oct 19, 2025
Location:
Navi Mumbai, India,
Company: Teva Pharmaceuticals
Job Id: 63035
**Who we are**
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
**The opportunity**
The Director, Regulatory Affairs - Post-Approval (US Generics) is a senior regulatory leader responsible for independently setting the strategic direction and ensuring the successful execution of all post-approval regulatory activities for U.S. FDA-regulated generic drug products. This role provides regulatory leadership across the organization, ensuring compliance with FDA regulations and guidances, while driving continuous improvement in lifecycle management processes. The Director leads a team of regulatory professionals and serves as a key liaison with the FDA, internal stakeholders, and external partners.
**How you'll spend your day**
+ Define and lead the global regulatory strategy for post-approval lifecycle management of U.S. FDA-approved ANDAs/NDAs, ensuring alignment with business goals and regulatory expectations.
+ Oversee the preparation, review, and submission of all CMC post-approval regulatory filings, including CMC Supplements (CBE-0, CBE-30, and PAS), Annual Reports (both active and inactive), REMS updates, general correspondences and controlled correspondences
+ Serve as the primary regulatory authority on post-approval matters, providing expert guidance to executive leadership and cross-functional teams.
+ Lead regulatory assessments and decision-making for complex changes, including site transfers, formulation changes, alternate APIs, etc.
+ Establish and maintain strong relationships with FDA project managers.
+ Monitor and interpret evolving FDA regulations, guidances, and enforcement trends; proactively adapt strategies and internal processes.
+ Develop and implement regulatory policies, SOPs, and training programs to ensure consistent and compliant practices across the organization.
+ Lead, mentor, and develop a high-performing regulatory team, fostering a culture of accountability, innovation, and continuous learning.
+ Represent Regulatory Affairs in global governance forums, strategic planning sessions, divestment assistance and support of internal initiatives.
+ Initiate/manage notices of commercial launch and product obsoletion, as well as updates to the Orange Book.
**Your experience and qualifications**
+ Pharm Dor M. Pharma in a scientific discipline.
+ Minimum 15+ years of pharmaceutical industry experience, with at least 10+ years in U.S. Regulatory Affairs focused on managing the lifecycle of generic drug products.
+ Proven leadership (8+ years in a supervisory role) in independently managing a large regulatory team, as well as a large and diverse post-approval portfolio consisting of various, globally manufactured dosage forms and complex supply chains.
+ Deep expertise and applied knowledge of FDA regulations (21 CFR 314.70), ICH guidelines, and eCTD submission standards.
+ Experience with regulatory systems (e.g., Veeva, TrackWise) and electronic document management systems (e.g. Wisdom, Glorya, Livelink, Knowledgetree).
+ Demonstrated success in leading regulatory strategy, agency interactions, and lifecycle management for ANDAs/NDAs.
+ Strong business acumen and ability to align regulatory strategies with commercial and operational objectives, while maintaining regulatory compliance.
+ Demonstrates a basic understanding of pharmaceutical drug development.
+ Demonstrated/proven track record of FDA interactions, as well as negotiation and influencing skills.
+ Demonstrates excellent verbal and written communication skills.
+ Experience working in a matrixed, multinational environment, as well as with third parties.
+ Experience with regulatory intelligence, policy shaping, and industry advocacy is a plus.
+ Lean Six Sigma certification, or other accreditation related to improving business processes is a plus.
**Already Working @TEVA?**
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site ( internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
**Teva's Equal Employment Opportunity Commitment**
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran
Associate, Regulatory Affairs
Posted today
Job Viewed
Job Description
# - Mumbai, Maharashtra, India
**Who We Are**
Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and territories under brands such as Colgate, Palmolive, elmex, hello, meridol, Sorriso, Tom's of Maine, EltaMD, Filorga, Irish Spring, PCA SKIN, Protex, Sanex, Softsoap, Speed Stick, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill's Pet Nutrition.
We are recognized for our leadership and innovation in promoting sustainability and community wellbeing, including our achievements in decreasing plastic waste and promoting recyclability, saving water, conserving natural resources and improving children's oral health.
If you want to work for a company that lives by their values, then give your career a reason to smile and join our global team!
**Brief introduction - Role Summary/Purpose :**
This position will manage and maintain product compliance during the whole life-cycle, for any category of products. This position will report to the Team Lead, Regulatory Operations.Engage proactively with diverse cross-functional teams, including R&D, legal, regulatory, and marketing departments, to meticulously develop and rigorously review all ingredient lists. This collaborative effort is crucial to guarantee the utmost accuracy and comprehensiveness of each list, ensuring full compliance with all relevant regulations and internal company standards. The objective is to achieve complete alignment across all stakeholders, from initial concept to final product launch, preventing discrepancies and ensuring transparency.
**Responsibilities:**
+ Responsible for developing/reviewing accurate and comprehensive ingredient lists while collaborating closely with cross-functional stakeholders to ensure alignment and timely updates. Manage and maintain a detailed tracking system to monitor ingredient list status, changes and requirements, facilitating smooth communication and efficient project progress.
+ Work closely with and support the Regional Regulatory Affairs Department in new product registration and life-cycle management of CP portfolio, including but not limited to, product renewals, variations, notifications and/or new license applications.
+ Support the regulatory strategy defined at Regional and/or Global level, and report regularly the progress to the Regional Regulatory Affairs Department with relevant KPIs, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation.
+ Compile documents and information required for high quality and successful submissions, license renewals and annual registrations, and maintenance of product registration dossiers for Authorities and Notified Bodies.
+ Keep track of outstanding documentation and open queries from Authorities, and notify the relevant Regional Regulatory Affairs manager in a timely manner.
+ Update and maintain product registration and ingredients archives, databases and tracking tools.
+ Upload and maintain as required by the Regional RA team any documentation supporting the placing of the market of other categories of products eg cosmetics, home care, consumer goods.
+ Work closely with Global and third party business partners to obtain the relevant documents and information for product dossiers.
+ Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.
+ Manage the distribution lists of SOP and the archiving in the documentation system.
Artwork Approval:
+ Assist the Regional Regulatory Affairs managers in the review of list of ingredients for labeling purposes (e.g. INCI and INDI).
+ Assist the Regional Regulatory Affairs managers with artwork review and approval
Regulatory intelligence and product advocacy activities:
+ Understand current regulations, guidelines and standards relevant to ensure compliance to the applicable regulatory and corporate standards/requirements (medicinal products, medical devices, cosmetic products, biocides, detergents, consumer goods).
+ Ensure that the content, organization and overall quality of all regulatory documents are adequate and compliant with local/regional regulatory requirements, commitments and agreements.
+ Track Competent Authority websites and databases for news related to new product registrations.
+ Assist Regional Regulatory team to deliver and manage Regulatory Assessment
**Required Qualifications :**
+ BS degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred.
+ Minimum 1 year of relevant experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries.
+ Understanding of registration and regulatory requirements in Africa Eurasian and Asia Pacific countries.
+ Knowledge of industry practices, techniques and standards.
+ Excellent computer skills, which includes working with Google Suite, electronic databases, eCTD software, MS Office applications, Adobe Acrobat Standard or Professional, SAP, DMS, and Authority Regulatory databases and portals for managing changes and submissions.
**Preferred Qualifications:**
+ Good written and verbal communicator with excellent interpersonal skills.
+ Good planning and organizing skills.
+ Ability to work under stress and meet deadlines.
+ Fluency in spoken and written English is mandatory.
+ Fluency in languages is advantageous.
#CPIL #LI-AP1
**Our Commitment to Sustainability**
With the Colgate brand in more homes than any other, we are presented with great opportunities and new challenges as we work to integrate sustainability into all aspects of our business and create positive social impact. We are determined to position ourselves for further growth as we act on our 2025 Sustainability & Social Impact Strategy.
**Our Commitment to Diversity, Equity & Inclusion**
Achieving our purpose starts with our people - ensuring our workforce represents the people and communities we serve -and creating an environment where our people feel they belong; where we can be our authentic selves, feel treated with respect and have the support of leadership to impact the business in a meaningful way.
**Equal Opportunity**
Employer Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.
Reasonable accommodation during the application process is available for persons with disabilities. Please contact with the subject "Accommodation Request" should you require accommodation.
#LI-On-site