Associate Manager I - Reg CMC Strategy, NP CMC Support
Confirmed on the employer's own hiring board on Nov 5, 2026. First seen by Alion on Nov 5, 2026. Pfizer scores A on the Alion truth index.
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 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
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.
Basiclevelofknowledgeongeneralstandards,processesandpoliciesofPfizer/Pharmaceutical manufacturing Industry.
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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Regulatory Affairs