Senior Director, Regulatory Affairs
Remote · New York City, New York, United States or US
Job Summary
The Senior Director of Regulatory Affairs will establish regulatory direction for the development of complex inhalation products, coordinating with R&D and other functional teams to ensure timely high-quality submissions. Responsibilities include developing regulatory strategies, reviewing ANDAs, and interacting with the FDA for regulatory filings. The ideal candidate will have a robust record in submissions, excellent communication skills, and experience managing regulatory staff and cross-functional teams.
Required Qualifications
- MS or PhD in physical, pharmaceutical, biological, or other life sciences
- A minimum of 10 years of hands-on regulatory experience
- 5 years in a management role
- 8-10 years of experience with successful submissions and approvals of ANDA/NDA (505B2) applications to the FDA
- A history of interaction with the OGD/OND Divisions of the FDA
Desired Qualifications
- Experience with complex generics products such as respiratory products/devices for the US
- Experience in drug development (CMC and PK/PD Clinical development)
- Strong team management and developing skill set
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