Description
We are seeking a Regulatory CMC Strategist to provide functional support to the Regulatory CMC Strategist for the Annual Reports & License Renewals, Innovative Products Team.
The successful candidate will work closely with the CMC Global Regulatory Strategist – CMC (GRS‑CMC) and cross‑functional teams to prepare and submit CMC contributions for Renewal and Annual Report applications across global markets.
Responsibilities:
- Manage day‑to‑day work activities associated with assigned renewal applications within agreed‑upon timelines
- Develop renewal regulatory strategies while considering registered content
- Prepare CMC contributions for renewal applications for assigned products across global markets
- Coordinate Module 1 and Module 3.2.R ancillary documents
- Review technical and supporting information for submission to support renewal applications
- Develop technical justifications for changes for agency submissions
- Support / Author query responses and/or commitment management
- Liaise with Pfizer Global Supply and other support functions
- Review and apply relevant regulatory guidelines for authoring renewal documentation
- Make decisions to resolve minor to moderate issues in standard situations
- Coordinate internal document review and sign‑off activities
- Utilize Pfizer systems to build expertise and guide or mentor colleagues
- Ensure compliance with assigned PLAs, Pfizer compliance training requirements, and Activity Tracker updates
Requirements:
- Minimum – Postgraduate in Pharmacy / Science Bachelors or Master (Biotechnology/ Pharmacy/ Science) or Ph. D (Biotechnology/Biological Sciences)
- 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
- 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
Technical Skills:
- Regulatory requirements of post approval changes for global market
- Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of License Renewals
- 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