Associate Manager I – Reg CMC Strategy, NP CMC Support – Pfizer, Mumbai / Chennai

Job Description

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).

Qualifications

• 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 new 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 conceptual, analytical, problem solving, and organizational skills. An assertive, take-charge, proven manager with a strong result orientation, positive “can do” attitude, and a sense of urgency to get things done. Can makes decisions to resolve moderately complex problems in standard situations. Makes decisions within guidelines, policies & procedures. Can work independently in ambiguous situations as part of a work team

Skills Required

• Ø Technical Skills:
• o Regulatory requirements of post approval changes for global market.
• o Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of License Renewals.
• o Knowledge in retrieving information from company’s and regulatory agency databases.
• Basic level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.

Additional Information

Always verify vacancy details and availability on the employer’s official website. Jobs Bio Help Learning is an independent job-discovery platform and does not process applications.