Associate I-Reg CMC Strategy

Associate I-Reg CMC Strategy

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 (e.g., Module 1, Module 2.3.S/P, and Module 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 for authoring renewal documentation.
• Executes the regulatory strategy for renewals while considering registered content and seeks endorsement from GRS‑CMC and/or RRHS.
• Reviews technical and supporting information for submission to support renewal applications.
• Updates impacted dossier components, as required; escalates timeline delays and contributes to the identification and mitigation of risks with support from 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.

• Preferred Education:

Minimum – Postgraduate in Pharmacy / Science

• Preferred Experience:

Minimum 0 - 1 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization. Excellent oral and written English communication skills. Good conceptual and reasoning skills. Attention to details.

• Preferred Attributes:

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:
  • Regulatory requirements of post approval changes for US
  • Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of ARs.
  • 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

Experience Level

Mid Level