Associate II, Reg CMC Strategy

Pfizer

About the Role

Functions as a CMC strategist for the development of CMC regulatory strategies, submissions, and compliance activities for commercial pharmaceutical products supporting HBU's Business. Provides and drives strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering post-approval activities.

Key Responsibilities

• Prepares the CMC information for submission to global regulatory agencies.
• Generates and drives CMC strategies.
• Assesses risks and develops contingency/mitigation plans.
• Acts as the global CMC representative within cross-functional project teams, interpreting regulations and guidelines and assessing global implications for strategic CMC decisions.
• Primary accountability for assigned CMC products, managing daily delivery of regulatory and strategic activities, including post-approval changes and compliance activities.
• May represent CMC during interactions with internal partners.
• Resolves issues and manages regulatory risks within project teams.
• Makes decisions to resolve moderate problems in standard situations per guidance and policies, and escalates complex issues/risks.
• Ensures compliance to Pfizer's training activities and individual development plans.
• Participates in cross-disciplinary forums and learning opportunities, demonstrating and modeling adherence to all Pfizer behaviors and values.
• Utilizes Pfizer's CMC systems, including GDMS, PDM, SPA, Rosetta, as appropriate.

Requirements & Tech Stack

• CMC systems: GDMS, PDM, SPA, Rosetta
• Regulatory Affairs

Qualifications

• Work is periodically reviewed by Team Lead.
• Role requires adherence to Principles of Integrity.
• Work Location Assignment: Hybrid