Plan and direct the preparation, development, implementation and submission of a consolidated regulatory strategy to secure the approval of the New Drug Applications (NDA); lead the site transfer and post-approval life cycle management of the NDAs.
Plan, review and approve strategic regulatory documents and submission materials used to support strategic regulatory discussions with FDA; serve as the primary strategic regulatory interface with the product development team and coordinate with regulatory personnel of contract manufacturing companies; provide regulatory support to Marketing, Manufacturing, Research and Development, and Quality Control departments on regulatory and compliance issues; ensure successful submissions to and approvals from the FDA; and supervise preparation, review and approvals of labels, inserts and cartons.
Requires BS in pharmacy, pharmaceutical sciences or related field plus 3 years' experience.
Location: East Brunswick, New Jersey
Mail resumes to Casper Pharma, LLC- 2 Tower Center Blvd., Suite 1101C, East Brunswick, New Jersey 08816