Regulatory CMC Manager – Small Molecule

This is a fully remote position, open to applicants in United States.

📋 Description

• Accountable for the comprehensive planning, preparation, and operational implementation of a multi-product program in the international sector.

• Aids in the preparation and submission of regulatory CMC documentation.

• Implements Lifecycle Management (LCM) strategies and submissions for marketed products, focusing on international regions.

• Plans and executes international regulatory CMC submissions.

• Reviews CMC components of regulatory submissions.

• Collaborates with regulatory colleagues to develop global regulatory CMC strategies and submissions.

• Actively participates in cross-functional teams and may act as the primary regulatory CMC contact for designated products and projects.

⛳️ Requirements

• Bachelor's degree preferred in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or a related life-science discipline.

• Typically requires 5 years of experience in the pharmaceutical industry or a related field.

• Experience in supporting Small Molecule programs is mandatory.

🏝️ Benefits

• Eligible for overtime compensation, in compliance with federal and state regulations.