Oversees and drives the development and submission of regulatory filings. Participates in the development of regulatory strategy and implementation plans, and ensures that these plans are executed and satisfy regulatory requirements. Drives for rapid and timely approval of regulatory submissions. Oversees all regulatory activities and staff at the Princeton, New Jersey location. Ensures that approved product applications are maintained in compliance with regulatory filing requirements. Provides regulatory advice to global cross-functional teams on project-related regulatory matters. Interacts with regulatory agency (primarily FDA) personnel. Oversees and maintains regulatory reporting schedules.
- Provide strong RA leadership at the Princeton, New Jersey site
- Partner with global development and technical operations teams to develop quality DMFs, ANDAs, NDAs, amendments and supplements
- Ensure regulatory compliance with pre-and post-approval filing and reporting requirements
- Manage associates career development, and performance, and develop associates to their full potential
- Represent US Regulatory Affairs at internal (global and US) and external meetings
- Interact with regulatory agencies (primarily US FDA).
B.S. degree required, a MS in a scientific /related discipline strongly preferred.
Minimum of 12 years of regulatory experience required including previous supervisory experience. Experience with generic drugs preferred.