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 Provides functional support to the Brands CMC Strategist for the License Renewals and Annual Reports team, working closely with the CMC Global Regulatory Strategist - CMC (GRS‑CMC) and cross‑functional teams (RRHS/PCO/RCM/Site CNM) to prepare and submit CMC contributions for Renewal and Annual Report applications across global markets, in line with defined timelines. JOB RESPONSIBILITIES Manages day-to-day regulatory activities associated with assigned Renewals and Annual Reports within agreed upon timelines under the guidance of Team Lead / designee. Renewals CMC Responsibilities: Demonstrates Fundamental Knowledge of Process Principles and Concepts; Activities Include, but Are Not Limited to: Provides support to Renewal Strategists in the preparation of CMC contributions for renewal applications for assigned products across global markets.



Authors and/or compiles CMC contributions for renewals, including Modules 1, 2.3.S/P, and 3.2.S/P/R/A; collaborates with GRS‑CMC and RRHS, as appropriate, and within agreed timelines. Liaises with Pfizer Global Supply and other support functions, as needed. Applies relevant regulatory guidelines in the authoring of renewal documentation. Executes the regulatory strategy for renewals while considering registered content and seeks endorsement from GRS‑CMC and/or RRHS; supports query and/or commitment management in collaboration with GRS‑CMC. Reviews technical and supporting information for submission to support renewal applications. Updates impacted dossier components, as required; escalates timeline delays and supports risk identification and mitigation in collaboration with the Team Lead (TL) or designee; flags identified risks to the CMC GRL and/or appropriate leadership. Coordinates Module 1 and Module 3.2.R ancillary documents, as neede

📌 Associate II (Chennai)
🏢 Pfizer
📍 Chennai