This job is with Pfizer, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly. JOB SUMMARY Execution of CMC strategies for Pfizer Global Supply (PGS) initiated prioritized post approval changesglobally in collaboration with the CMC GRS. Responsible for development and execution of regulatory strategiesincluding response to HA queries. Manages day-to-day regulatory activities associated with assigned PCFs within agreed upontimelines. Collaborates with Cross Functional Teams (RRHS/PCO/RCM/Site CNM) and GRS-CMC to ensure thedeliverables. Works in a structured workplace with supervision from Team Lead. Liaise with Pfizer Global Supply and other support functions as needed. Use of regulatory systems and management of CMC documentation and information in support ofthe CMC GRS.



JOB RESPONSIBILITIES Functions as CMC author/strategist for development and execution of regulatory strategies for theassigned changes which include minor and/or moderate post approval changes/projects/products Responsible for end to end PCF assessment Authors and compiles response to HA queries within agency timelines Projects involving complex CMC changes shall be assigned through mentoring as a part of careerdevelopment, if identified Reviews proposed changes for completeness and accuracy and development of initial globalregulatory strategy while considering registered content and seeks endorsement by the CMC GRS. Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMCsubmission packages globally, i.e.Module 1, Module 2.3, M3.2S/P/R under guidance from the CMCGRS as appropriate and within agreed timelines. Major and Emerging Market focused Reviews technical/supportive information for submission to support change Reviews and applies pertinent global regulatory guidelines Develops technical justification of change for agency submission Updates M3 dossier Coordinat

📌 Associate Manager I – Reg CMC Strategy (Chennai)
🏢 Pfizer
📍 Chennai