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.

 
Work Location Assignment: On Premise

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