Pfizer is hiring for the position of Associate II – Regulatory Strategy, GRS Oncology in Chennai, Tamil Nadu. The role is part of the company’s Global Regulatory Strategic team and focuses on regulatory strategy, product lifecycle activities, CMC submissions, labeling, safety compliance, and Health Authority support.
The position is offered on a full-time, hybrid basis. Pfizer is looking for professionals with a background in pharmacy, life sciences, chemistry, biotechnology, or a related discipline, along with preferably 2–4 years of relevant pharmaceutical industry experience.
The role involves collaboration with Global Regulatory Leads, product teams, CMC Regulatory, clinical, safety, labeling, quality, supply, commercial, publishing, and country regulatory teams.
Pfizer Recruitment 2026 – Job Highlights
| Particulars | Details |
|---|---|
| Company | Pfizer |
| Position | Associate II – Regulatory Strategy, GRS Oncology |
| Department | Regulatory Affairs |
| Job Location | Chennai, Tamil Nadu |
| Other Location Mentioned | APAC – Any Pfizer Site |
| Work Mode | Hybrid |
| Employment Type | Full Time |
| Experience | Preferably 2–4 Years |
| Qualification | Bachelor’s/Master’s in Pharmacy, Life Sciences, Chemistry, Biotechnology or related field |
| Functional Area | Regulatory Strategy / Regulatory Affairs |
| Job Requisition ID | 4964681 |
| Salary/CTC | Not Disclosed |
| Posted | Today |
About Pfizer
Pfizer is a global pharmaceutical company involved in the research, development, manufacturing, and delivery of medicines and vaccines.
For this position, the Global Regulatory Strategic team works on regulatory activities required to maintain pharmaceutical products throughout their lifecycle. The role supports regional regulatory strategies and coordinates submissions and related activities across global and country-level teams.
Pfizer Associate II – Regulatory Strategy Job Description
The Associate II will support regulatory strategy and lifecycle management activities for assigned products and regions.
The position involves coordinating regulatory submissions, preparing and reviewing CMC-related documents, supporting Health Authority responses, managing labeling and safety-related activities, and ensuring regulatory deliverables are completed accurately and on time.
Regulatory Strategy and Lifecycle Management
The selected candidate will:
- Coordinate lifecycle maintenance activities for assigned products.
- Support variations, supplements, amendments, renewals, withdrawals, and post-approval commitments.
- Contribute to regional regulatory strategies in coordination with relevant stakeholders.
- Ensure regional and country-level submission approaches remain aligned with global regulatory strategies.
- Work with stakeholders to support regulatory activities in line with product and business requirements.
CMC Submission Operations and eAF
Responsibilities related to CMC regulatory operations include:
- Prepare and quality-check electronic applications and cover letters.
- Support preparation of regulatory submission packages.
- Review eAF CMC content for completeness and accuracy.
- Check submitted information against approved regulatory strategies and source documents.
- Identify gaps in existing processes.
- Contribute to simplification, standardization, automation, and continuous improvement of regulatory workflows.
Submission Preparation and Health Authority Support
The role will also support preparation and coordination of regulatory submissions.
Key activities include:
- Prepare and coordinate cover letters and application forms.
- Support response documents and regulatory commitments.
- Review declarations, product information, and administrative documentation.
- Coordinate inputs required for Health Authority questions.
- Consolidate comments and check responses for consistency.
- Support timely delivery of responses.
- Work with regional and country regulatory colleagues to understand submission requirements.
- Assist with implementation activities following regulatory submissions or decisions.
Labeling, Safety and Aggregate Reporting
The Associate II may support regulatory activities associated with:
- Core and local labeling updates
- Labeling impact assessments
- Submission planning
- Labeling implementation tracking
- Reconciliation activities
- Aggregate reports
- Risk-management documents
- Post-authorization safety commitments
- Post-authorization efficacy commitments
- Safety compliance reporting
The role may also involve generating Pearl reports and WWRS reports to support safety compliance activities, renewals, launches, and Health Authority queries when required.
Educational Qualification
Candidates should have a:
- Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related discipline; or
- Master’s degree in one of the relevant fields.
A Master’s degree in Pharmacy, Regulatory Affairs, Life Sciences, or a related discipline is listed as a preferred qualification.
Experience Requirements
The vacancy preferably seeks candidates with 2–4 years of relevant pharmaceutical industry experience, particularly in regulatory affairs or related activities.
Candidates should have working knowledge of:
- Pharmaceutical regulatory submissions
- Product lifecycle management
- Regulatory submission documentation
- Regulatory data management
- Regulatory trackers
- Submission coordination and review
Experience supporting complex product portfolios is an advantage.
Preferred Experience
The following experience can strengthen a candidate’s profile:
- Oncology products
- Specialty care products
- Biologics
- Post-approval variations
- Renewals
- Labeling changes
- Health Authority responses
- CMC submissions
- eAF processes
- Product data management
- Electronic submission tools
- Document management systems
- Regulatory information management systems
Knowledge of regulatory requirements in EU and/or US markets is also preferred.
Required Skills and Competencies
Candidates should demonstrate:
- Regulatory affairs knowledge
- Understanding of pharmaceutical product lifecycle activities
- Regulatory document preparation and review
- Strong attention to detail
- Critical thinking
- Strategic thinking
- Data-driven assessment
- Ability to manage multiple priorities
- Regulatory compliance awareness
- Strong written communication
- Strong verbal communication
- Presentation skills
- Stakeholder management
- Cross-functional collaboration
- Ability to work independently
- Ability to work effectively in a global matrix environment
Experience with process improvement, data analytics, automation, or approved AI tools in regulated environments is also considered beneficial.
Key Responsibilities
1. Regulatory Strategy and Lifecycle Execution
- Coordinate regulatory maintenance activities for assigned products and regions.
- Support variations, supplements, renewals, amendments, withdrawals, and post-approval commitments.
- Implement agreed regional regulatory strategies.
- Coordinate with global, regional, and country stakeholders.
- Ensure regulatory approaches are aligned across relevant teams.
2. Regulatory Submission Management
- Prepare and review regulatory application documents.
- Support CMC submission packages.
- Quality-check eAF information.
- Verify regulatory documents against source information.
- Identify inconsistencies or missing information before submission.
- Support improvements to regulatory submission workflows.
3. Health Authority Interactions
- Coordinate responses to Health Authority questions.
- Collect information and comments from relevant subject-matter teams.
- Consolidate response documentation.
- Check response packages for consistency and completeness.
- Support submission delivery within agreed timelines.
4. Labeling and Safety Activities
- Coordinate regulatory labeling updates.
- Support impact assessments and submission planning.
- Track implementation of approved labeling changes.
- Support aggregate reports and risk-management documentation.
- Track applicable post-authorization safety and efficacy commitments.
- Generate required regulatory and safety-related reports.
5. Cross-Functional Collaboration
- Work with Global Regulatory Leads and product teams.
- Coordinate with CMC Regulatory, Clinical, Safety, Labeling, Quality, Supply, Commercial, Publishing, and country regulatory teams.
- Participate in regulatory and project meetings.
- Communicate decisions and follow up on assigned actions.
- Provide support across products according to business priorities.
- Share knowledge and help colleagues understand established processes.
Key Deliverables and Success Measures
Performance in the role will be measured across several areas.
Timely delivery: Regulatory activities and assigned deliverables should be completed within agreed timelines, with material risks escalated appropriately.
Quality and accuracy: Submission documents and eAF CMC information should be complete, consistent, and accurate, minimizing avoidable rework.
Compliance: Regulatory and safety-related activities should be properly documented, tracked, and aligned with applicable requirements.
Stakeholder collaboration: Effective communication, timely follow-up, and coordination across global, regional, and country teams are important.
Continuous improvement: Contributions toward process simplification, standardization, automation, and reusable team resources are encouraged.
Work Location and Work Environment
The primary location listed for the position is Chennai, Tamil Nadu, India.
The vacancy also mentions APAC – Any Pfizer Site as a location option.
The work location assignment is Hybrid.
Specific shift timings have not been provided in the vacancy.
Salary / CTC
Pfizer has not disclosed the salary or CTC for this position in the available vacancy details.
Candidates should confirm the compensation structure and other employment terms during the recruitment process.
Selection Process
The vacancy does not specify the complete selection process.
Candidates should refer to Pfizer’s recruitment communication for information about interviews, assessments, or other hiring stages.
How to Apply
Interested and eligible candidates can apply through the official Pfizer Careers application page.
Candidates should review the eligibility requirements carefully and ensure their resume highlights relevant regulatory affairs, lifecycle management, CMC submissions, Health Authority responses, labeling, and pharmaceutical industry experience where applicable.
Important Details Before Applying
- Position: Associate II – Regulatory Strategy, GRS Oncology
- Company: Pfizer
- Location: Chennai, Tamil Nadu
- Work arrangement: Hybrid
- Employment type: Full Time
- Job Requisition ID: 4964681
- Relevant experience: Preferably 2–4 years
- Relevant qualifications: Pharmacy, Life Sciences, Chemistry, Biotechnology, or related disciplines
- Master’s degree is preferred.
- Regulatory submission and product lifecycle knowledge is important.
- Oncology, specialty care, biologics, or complex product experience is preferred.
- CMC and post-approval regulatory experience can be advantageous.
- Knowledge of EU and/or US regulatory frameworks is preferred.
- Salary/CTC has not been disclosed.
Frequently Asked Questions
1. What position is Pfizer hiring for?
Pfizer is hiring for an Associate II – Regulatory Strategy, GRS Oncology position.
2. Where is the job located?
The primary location is Chennai, Tamil Nadu, India. The listing also mentions APAC – Any Pfizer Site.
3. Is this a hybrid position?
Yes. The work location assignment is Hybrid.
4. What experience is preferred?
The vacancy preferably seeks candidates with 2–4 years of relevant pharmaceutical industry experience.
5. What educational qualifications are accepted?
Candidates should have a bachelor’s or master’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related discipline.
6. Is a master’s degree required?
A master’s degree is listed as a preferred qualification, rather than a basic requirement.
7. Is oncology experience required?
Oncology experience is listed under the preferred qualifications. Experience with specialty care, biologics, or other complex product portfolios is also preferred.
8. What regulatory activities are involved?
The position covers lifecycle maintenance, variations, supplements, renewals, withdrawals, post-approval commitments, CMC submissions, labeling activities, Health Authority responses, and safety-related regulatory work.
9. What skills are important for this role?
Important skills include regulatory knowledge, strategic thinking, critical analysis, attention to detail, communication, presentation, stakeholder management, and the ability to manage multiple priorities.
10. What is the salary for the Pfizer Associate II role?
The salary or CTC has not been disclosed in the available job posting.
Important Note
Job responsibilities, eligibility criteria, location assignments, work arrangements, compensation, and recruitment conditions may change during the hiring process. Candidates should verify the latest information on the official Pfizer Careers page before applying.