Associate Manager I - Reg CMC Strategy, NP CMC Support

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 procedur