Job Description
The Director I Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers and management in RA, R&D, and Operations. Serves as strategic liaison with regulatory agencies (e.g., FDA) regarding CMC matters. May include formal supervisory responsibilities. Manages assigned projects within assigned resources.
Responsibilities
List up to 10 main responsibiliti...