Pfizer Hiring Associate II, Regulatory CMC Strategy in Chennai
Pfizer hiring Chennai: Pfizer is hiring an Associate II, Reg CMC Strategy in Chennai, India. The full-time, hybrid role requires B.Pharm, M.Pharm, Pharm.D, M.Sc or M.Tech qualifications and 2-4 years of experience in regulatory affairs / CMC.
Job Details
- Company: Pfizer
- Position: Associate II, Reg CMC Strategy
- Location: Chennai, India
- Job Requisition ID: 4966490
- Posted On: 27 October 2026
- Employment Type: Full-time
- Work Mode: Hybrid
Job Description
The role functions as a CMC strategist developing CMC regulatory strategies, submissions and compliance activities for commercial pharmaceutical products supporting Pfizer’s Hospital Business Unit, with work periodically reviewed by a Team Lead.
Key Responsibilities
- Provide and drive strategic and operational global CMC regulatory direction and documentation for assigned products covering post-approval activities.
- Prepare CMC information for submission to global regulatory agencies.
- Generate CMC strategies, assess risks and develop contingency/mitigation plans.
- Act as the global CMC representative within cross-functional project teams, interpreting regulations and guidelines.
- Manage daily delivery of regulatory activities including post-approval changes and compliance.
- Resolve moderate issues and escalate complex risks.
- Use Pfizer CMC systems such as GDMS, PDM, SPA and Rosetta.
Eligibility Criteria
- Qualification: B.Pharm / M.Pharm / Pharm.D / M.Sc / M.Tech
- Experience: 2-4 years in regulatory affairs / CMC
How to Apply
Apply online on the Pfizer Workday careers page. Apply only through the official notification / employer link given here.
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
Apply online through the Pfizer Workday careers page.