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Provides functional support to the Regulatory CMC Strategist for the Annual Reports & License Renewals, Innovative Products Team, working closely with the CMC Global Regulatory Strategist - CMC (GRS‑CMC) and cross‑functional teams (RIO EH/PCO/RCM/Site CNM) to prepare and submit CMC contributions for Renewal and Annual Report applications across global markets, in line with defined timelines.

Individual Contributor - responsible for own work (requiring periodic review) under general supervision:

Renewals CMC Responsibilities:

Demonstrates Strong Knowledge and Understanding of Process Principles and Concepts; Activities Include, but Are Not Limited to:

- Manages day‑to‑day work activities associated with assigned renewal applications within agreed‑upon timelines; utilizes Pfizer systems (e.g., PEARL, GDMS, PDM, SPA), as appropriate.
- Develops renewal regulatory strategies while considering registered content, in collaboration with GRS‑CMC and Group Lead.
- Prepares CMC contributions for renewal applications for assigned products across global markets; authors and/or compiles renewal documentation (e.g., Module 1, Module 2.3.S/P, and Module 3.2.S/P/R/A) under the guidance of GRS‑CMC and/or Group Lead and within agreed timelines.
- Coordinates Module 1 and Module 3.2.R ancillary documents, as needed.
- Reviews technical and supporting information for submission to support renewal applications.
- Develops technical justifications for changes for agency submissions, as required.




- Supports / Author query responses and/or commitment management in collaboration with GRS‑CMC.
- Liaises with Pfizer Global Supply and other support functions, as needed.
- Reviews and applies relevant regulatory guidelines for authoring renewal documentation.
- Makes decisions to resolve minor to moderate issues in standard situations in accordance with guidance and policies; escalates complex issues and identified risks to GRS‑CMC, Group Lead, and/or appropriate leadership.
- Coordinates internal document review and sign‑off activities.
- Utilizes Pfizer systems (e.g., PEARL, GDMS, PDM, SPA) to build expertise and may begin guiding or mentoring colleagues within the Renewals and/or cross‑brand teams.
- Ensures compliance with assigned PLAs, Pfizer compliance training requirements, and Activity Tracker updates.

Annual Report CMC Responsibilities:

- Manages day-to-day regulatory activities associated with assigned Annual Reports within agreed upon timelines.
- Reviews changes made during the reporting period for completeness and accuracy. Develops initial Annual Report regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC.
- Authors and/or compiles CMC contributions based on changes made during the appropriate reporting period, i.e.



Module 1 & 3 under the guidance from the GRS-CMC as appropriate and within agreed timelines.

o Reviews all appropriate systems for post approval changes submitted and approved along with commitments made and fulfilled

o Reviews technical/supportive information for submission to support AR changes

o Manages and reviews stability contributions for accuracy and consistency with commitments

o Reviews and applies pertinent US regulatory guidelines to confirm Annual Reportable filing classifications.

o Develops technical justification of change for agency submission as needed

o Updates impacted dossier components as needed

o Coordinates M3.2.R Ancillary documents as needed

o Escalates delays in timelines and flags identified risks to the GRS-CMC and/or appropriate leadership

- Coordinates internal document review and sign off.
- Utilizes Pfizer's CMC systems, i.e. GDMS, PDM, SPA, Veeva) etc., as appropriate.
- Ensures compliance to Pfizer internal procedures and training SOPs (PLA).

Ø Preferred Education:

Minimum - Postgraduate in Pharmacy / Science Bachelors or Master (Biotechnology/ Pharmacy/ Science) or Ph. D (Biotechnology/Biological Sciences)

Ø Preferred Experience:

Minimum 4-6 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization handling current submissions and / or LCM submission to global health authorities especially USFDA, EMA and other EU authorities. Experience in CMC strategy and legislation that pertains to Biologics and Biosimilars is preferable.

Ø Preferred Attributes:

Good oral and written English communication skills. Good c

📌 Associate Manager I (Mumbai)
🏢 Pfizer
📍 Mumbai