Pfizer Hiring 2026 – Associate II Reg CMC Strategy in Chennai
Looking for an opportunity to grow in Regulatory Affairs and CMC strategy?
Pfizer is hiring for the position of Associate II – Reg CMC Strategy at its Pfizer Centre in Chennai. The role is suited to pharmacy and science graduates with 2–4 years of independent Regulatory Affairs experience in the pharmaceutical industry.
The selected professional will support global license renewals, Annual Reports, CMC documentation, post-approval changes, and regulatory strategy.
About Pfizer
Pfizer is a global biopharmaceutical company focused on developing medicines and vaccines that address important healthcare needs.
The company combines scientific research, technology, and regulatory expertise across global markets. For professionals in Regulatory Affairs, CMC, clinical development, and pharmaceutical sciences, Pfizer provides exposure to complex international projects and highly regulated processes.
Job Overview
| Details | Information |
|---|---|
| Company | Pfizer |
| Position | Associate II – Reg CMC Strategy |
| Department | Regulatory Affairs – CMC Strategy |
| Location | Chennai, India |
| Experience | 2–4 Years |
| Qualification | Undergraduate/Postgraduate in Pharmacy or Science |
| Employment Type | Full-Time |
| Work Mode | On-site / As specified by employer |
| Job Requisition ID | 4963486 |
About the Associate II – Reg CMC Strategy Role
The selected candidate will work with the CMC regulatory strategy team and contribute to regulatory submissions associated with license renewals and Annual Reports.
The position requires a good understanding of pharmaceutical manufacturing, regulatory documentation, post-approval changes, and global submission requirements.
This is particularly relevant for professionals who want to build a career in Regulatory CMC, regulatory strategy, and global submissions.
Key Responsibilities
The Associate II will be responsible for activities such as:
- Prepare CMC contributions for license renewal applications
- Author and compile relevant regulatory dossier sections
- Work on Modules 1, 2.3.S/P and 3.2.S/P/R/A
- Support Annual Report submissions
- Review technical information for regulatory submissions
- Assess post-approval changes and reporting requirements
- Prepare technical justifications for regulatory authorities
- Track regulatory queries, commitments, and timelines
- Coordinate with global and cross-functional teams
- Review stability information and relevant CMC data
- Update dossier components when required
- Identify and escalate potential timeline risks
- Support preparation of ancillary documents
- Follow Pfizer procedures, training requirements, and SOPs
Eligibility Criteria
Candidates should have:
- An undergraduate or postgraduate degree in Pharmacy or Science
- 2–4 years of independent Regulatory Affairs experience
- Experience working in a pharmaceutical organization
- Understanding of regulatory requirements for post-approval changes
- Knowledge of pharmaceutical manufacturing processes
- Strong technical documentation skills
- Good written and verbal English communication
Professionals with experience in CMC regulatory affairs, renewals, Annual Reports, or global regulatory submissions may find this role particularly relevant.
Skills Required
The ideal candidate should have:
Regulatory & CMC Knowledge
- Regulatory Affairs fundamentals
- CMC documentation
- License renewal processes
- Annual Report requirements
- Post-approval change assessment
- Global regulatory submissions
Technical Skills
- Understanding of pharmaceutical manufacturing
- Ability to interpret technical information
- Regulatory database research
- Dossier preparation and document management
Professional Skills
- Strong analytical and reasoning ability
- Excellent attention to detail
- Problem-solving skills
- Time management
- Stakeholder coordination
- Clear communication
- Ability to manage multiple priorities
Global Regulatory Exposure
One of the major attractions of this position is the opportunity to work on regulatory activities associated with global markets.
The role involves applying regulatory guidelines to renewal and Annual Report documentation while coordinating with different internal functions.
This can help professionals develop valuable expertise in international CMC regulatory strategy.
Systems & Tools
The job description indicates exposure to Pfizer systems and regulatory workflows, including:
- PEARL
- GDMS
- PDM
- SPA
- Regulatory and company databases
- Standard MS Office tools and documentation systems
Experience with similar regulatory systems can be useful when transitioning into this position.
Career Opportunities
A role in Regulatory CMC Strategy can provide a strong foundation for future positions such as:
- Regulatory Affairs Specialist
- Regulatory CMC Specialist
- Senior Regulatory Affairs Associate
- CMC Regulatory Manager
- Regulatory Strategy Manager
Professionals can gradually develop expertise across CMC submissions, global regulations, lifecycle management, and regulatory strategy.
Why Consider This Pfizer Opportunity?
Working in this role can provide:
- Exposure to global pharmaceutical regulatory processes
- Experience with CMC regulatory strategy
- Learning opportunities in renewals and Annual Reports
- Cross-functional collaboration with global teams
- Experience working with complex regulatory documentation
- Professional development in a highly regulated environment
- Opportunity to build a long-term Regulatory Affairs career
How to Apply
This is an online application opportunity.
Candidates should apply through the official Pfizer careers portal and search using:
Job Title: Associate II – Reg CMC Strategy
Job ID: 4963486
Location: Chennai
Make sure your resume clearly highlights your experience in Regulatory Affairs, CMC submissions, renewals, Annual Reports, and post-approval activities.
Selection Process
The recruitment process may include:
- Online application
- Resume screening
- Initial recruiter discussion
- Technical / regulatory interview
- Hiring manager discussion
- Final HR discussion
- Offer and onboarding
The exact process can vary depending on the position and recruitment team.
Frequently Asked Questions
1. What position is Pfizer hiring for?
Pfizer is hiring an Associate II – Reg CMC Strategy in Chennai.
2. How much experience is required?
Candidates should have approximately 2–4 years of independent Regulatory Affairs experience.
3. What qualification is required?
An undergraduate or postgraduate degree in Pharmacy or Science is required.
4. Is this a Regulatory Affairs job?
Yes. The position is part of Regulatory Affairs – CMC Strategy and focuses on renewals, Annual Reports, CMC documentation, and regulatory strategy.
5. Where is the job located?
The position is based at the Pfizer Centre in Chennai, India.
6. What is the job requisition ID?
The Pfizer job requisition ID is 4963486.
7. Can freshers apply?
The listed requirement is 2–4 years of Regulatory Affairs experience, so this particular position is intended for experienced candidates rather than freshers.
8. Is this a walk-in interview?
No. Candidates should apply through the Pfizer careers portal.
