Pfizer Offices

Executes global CMC regulatory strategies for post-approval pharmaceutical changes, including product change assessments, health authority responses, regulatory submissions, dossier updates, and technical justifications. Coordinates cross-functional reviews, document sign-off, query and commitment management, risk escalation, and regulatory system maintenance. The role requires applying international regulatory guidelines and managing multiple projects under team-lead guidance.

Supports global pharmaceutical regulatory CMC activities for license renewals and annual reports. Authors and compiles CMC dossier contributions, reviews post-approval changes and stability information, applies regulatory guidelines, develops technical justifications, coordinates document reviews, manages commitments and queries, and updates submission components. Collaborates with global regulatory strategists, manufacturing, supply, and cross-functional teams while monitoring timelines, risks, compliance, and submission accuracy.

Supports CMC regulatory activities for pharmaceutical license renewals and annual reports across global markets. Responsibilities include authoring and compiling regulatory dossier contributions, reviewing technical and stability information, applying U.S. regulatory guidelines, coordinating document reviews and approvals, updating dossier components, managing timelines and risks, and using Pfizer regulatory systems. Requires postgraduate education in Pharmacy or Science and foundational knowledge of post-approval regulatory requirements.