Associate II, Reg CMC Strategy

Overview

Functions as a CMC strategist for the development of CMC regulatory strategies, submissions and compliance activities for commercial pharmaceutical products supporting HBU's Business.

What you'll do

• Work is periodically reviewed by Team Lead.
• Provide and drive strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering post approval activities.
• Prepare CMC information for submission to global regulatory agencies.
• Generate and drive CMC strategies, assess risks and develop contingency/mitigation plans.
• Act as the global CMC representative within cross-functional project teams, interpreting regulations and guidelines and assessing global implications for strategic CMC decisions.
• Be primary accountable for assigned CMC products, managing daily delivery of regulatory and strategic activities, including post-approval changes and compliance activities.
• Represent CMC during interactions with internal partners, either directly or in conjunction with Team Lead.
• Resolve issues and manage regulatory risks within project teams.
• Make decisions to resolve moderate problems in standard situations as per guidance and policies, and escalate complex issues/risks to appropriate leadership.
• Ensure compliance with Pfizer's training activities (e.g. functional, compliance-related, HR policies) and individual development plans; participate in cross-disciplinary forums and learning opportunities; demonstrate and model adherence to all Pfizer behaviors and values, embracing and complying with Principles of Integrity.
• Utilize Pfizer's CMC systems, i.e. GDMS, PDM, SPA, Rosetta, etc., as appropriate.

Details

• Work location assignment: Hybrid.
• Department: Regulatory Affairs.