Regulatory Affairs Manager.

Job Description:

Primary Role:
Under the general direction of the CMC Regulatory Affairs team, develop a Core Dossier for Module 2.3 and Module 3 CTD sections for a marketed product, and leverage the Core Dossier documents to support Marketing Authorization Applications for international regions. Manage preparation of Core Dossier and CMC components for international marketing applications in a timely manner to meet corporate objectives.

Responsibilities:

• 50% of the time develops global CMC Core Dossier for Module 2.3 and Module 3 CTD sections

• 50% of the time prepares CMC components of new Marketing Authorization Applications for international countries

• Someone who can review the current NDA.