Regulatory Affairs Manager provides regulatory guidance to project development teams and is responsible for coordination and assembly of regulatory documents for review and submission to FDA in support of a clinical development program for new pharmaceutical products.
The Manager, Regulatory Affairs is also responsible for providing advice on the strategy for the clinical development program, and for filing necessary submissions to FDA, including IND and IND amendments, and for handling all FDA interactions.
Primary Duties and Responsibilities Coordinates strategy and assembles regulatory and clinical documents for review and submission to FDA for the clinical development program Responsible for filing IND applications and IND amendments, and for handling all interactions with the FDA.