Associate II – Reg CMC Strategy

Job description

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 emplo