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 needed.
- Coordinates internal document review and sign‑off activities.
- Utilizes Pfizer systems (e.g., PEARL, GDMS, PDM, SPA), as appropriate.

Annual Report (AR)

📌 Associate II (Chennai)
🏢 Pfizer
📍 Chennai