Associate II – Reg CMC Strategy

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 authoring of query 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 issues in standard situations in accordance with guidance and policies; escalates complex issues and identified risks to GRS‑CMC, line manager, and/or appropriate leadership.
• Coordinates internal document review and sign‑off activities.
• Utilizes Pfizer systems (e.g., PEARL, GDMS, PDM, SPA, Veeva) to build expertise and may begin guiding or mentoring colleagues within the Renewals and/or cross‑global brand teams.
• Ensures compliance with assigned PLAs, Pfizer compliance training requirements, and Activity Tracker updates.

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

 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.
  • Reviews all appropriate systems for post approval changes submitted and approved along with commitments made and fulfilled
  • Reviews technical/supportive information for submission to support AR changes
  • Manages and reviews stability contributions for accuracy and consistency with commitments
  • Reviews and apply current Agency’s regulatory guidelines to confirm Annual Reportable filing classifications.
  • Develops technical justification of change for agency submission as needed
  • Updates impacted dossier components as needed
  • Coordinates M3.2.R Ancillary documents as needed
  • Escalates delays in timelines and flags identified risks to the GRS-CMC and/or appropriate leadership
• Coordinates internal document review and required approval sign off’s.
• 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 / SKILLS

·       Preferred Education:

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

·       Preferred Experience:

Minimum 3-5 Years of experience in Pharmaceutical Industry with major experience in Regulatory Affairs group 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.

·       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

·       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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.