Pfizer Hiring Associate Manager I – Reg CMC Strategy in Chennai

Pfizer has opened recruitment for the position of Associate Manager I within its Regulatory CMC Strategy division. The role is focused on managing, authoring, and executing global post-approval Chemistry, Manufacturing, and Controls (CMC) strategies and submissions across both major and emerging markets.

Interested candidates meeting the required technical criteria can submit their applications online before the closing date on October 10, 2026.

Core Responsibilities & Workflow

Post-Approval Change Execution: Plan and execute regulatory strategies for Pfizer Global Supply (PGS) initiated prioritized post-approval changes in collaboration with Global Regulatory Sciences (CMC GRS).
Dossier Compilation & Authoring: Draft and compile Regulatory Strategy Documents (RSD) along with global CMC submission packages across Module 1, Module 2.3, and Module 3 (M3.2.S, M3.2.P, M3.2.R ancillary documents).
Agency Interactions & Query Resolution: Author, review, and compile technical justifications and responses to Health Authority (HA) queries within stipulated agency timelines.
Cross-Functional Synergy: Liaise with PGS, RRHS, PCO, RCM, and Site CNM to review technical documentation, assess Plant Change File (PCF) workflows end-to-end, and align deliverables.
Internal Systems & Conformance: Utilize enterprise CMC and regulatory tools, including GDMS, PDM, SPA, and TrackWise, to maintain conformance and regulatory documentation integrity.

Candidate Qualifications & Experience

Educational Background: Postgraduate degree (Master’s) in Pharmacy (M.Pharm) or Science (M.Sc.).
Experience: 3 to 7 years of specialized CMC experience within a regulatory affairs function.
Regulatory Acumen: Strong working knowledge of US FDA, EU EMA, and international guidelines governing post-approval CMC variations and lifecycle maintenance.
Technical Skills: Hands-on proficiency with TrackWise, electronic document management systems (EDMS), navigation tools, and regulatory publishing workflows.

Key Opportunity Summary