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