JOB SUMMARY
Provides functional support to the Brands CMC Strategist for the License Renewals and Annual Reports team, working closely with the CMC Global Regulatory Strategist – CMC (GRS‑CMC) and cross‑functional teams (RRHS/PCO/RCM/Site CNM) to prepare and submit CMC contributions for Renewal and Annual Report applications across global markets, in line with defined timelines.
JOB RESPONSIBILITIES
Manages day-to-day regulatory activities associated with assigned Renewals and Annual Reports within agreed upon timelines under the guidance of Team Lead / designee.
Renewals CMC Responsibilities:
Demonstrates Fundamental Knowledge of Process Principles and Concepts; Activities Include, but Are Not Limited to:
- Provides support to Renewal Strategists in the preparation of CMC contributions for renewal applications for assigned products across global markets.
- Authors and/or compiles CMC contributions for renewals, including Modules 1, 2.3.S/P, and 3.2.S/P/R/A; collaborates with GRS‑CMC and RRHS, as appropriate, and within agreed timelines.
- Liaises with Pfizer Global Supply and other support functions, as needed.
- Applies relevant regulatory guidelines in the authoring of renewal documentation.
- Executes the regulatory strategy for renewals while considering registered content and seeks endorsement from GRS‑CMC and/or RRHS; supports query and/or commitment management in collaboration with GRS‑CMC.
- Reviews technical and supporting information for submission to support renewal applications.
- Updates impacted dossier components, as required; escalates timeline delays and supports risk identification and mitigation in collaboration with the Team Lead (TL) or designee; flags identified risks to the CMC GRL and/or appropriate leadership.
- Coordinates Module 1 and Module 3.2.R ancillary documents, as needed.
- Coordinates internal document review and sign‑off activities.
- Utilizes Pfizer systems (e.g., PEARL, GDMS, PDM, SPA), as appropriate.
Annual Report (AR) CMC Responsibilities
- Reviews changes implemented during the reporting period for completeness and accuracy; develops the initial Annual Report regulatory strategy while considering registered content and seeks endorsement from the CMC GRL.
- Authors and/or compiles CMC contributions based on changes made during the applicable reporting period (e.g., Modules 1 and 3), under the guidance of the CMC GRL, within agreed timelines.
- Reviews all relevant systems to confirm post‑approval changes submitted and approved, including commitments made and fulfilled.
- Reviews technical and supporting information for submission to support Annual Report changes.
- Manages and reviews stability contributions to ensure accuracy and consistency with approved commitments.
- Reviews and applies relevant U.S. regulatory guidelines to confirm appropriate Annual Reportable filing classifications.
- Develops technical justifications for changes for agency submission, as needed.
- Updates impacted dossier components, as required.
- Coordinates Module 3.2.R ancillary documents, as needed.
- Escalates timeline delays and flags identified risks to the CMC GRL and/or appropriate leadership.
- Coordinates internal document review and sign‑off activities.
- Utilizes Pfizer CMC systems (e.g., GDMS, PDM, SPA), as appropriate.
- Ensures compliance with Pfizer internal procedures and training SOPs (PLA).
QUALIFICATIONS / SKILLS
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
Minimum – Undergraduate/Postgraduate in Pharmacy or
Science
Minimum 2 - 4 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization
Excellent oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. Good conceptual and reasoning skills. Attention to details.
- Technical Skills:
- Knowledge on Regulatory requirements of post approval changes for global market.
- 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.
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