Senior Director Regulatory Affairs, CMC
$204,500–$274,500 year
Remote · New York City, New York, United States or US
Job Summary
This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities. Responsibilities include leading a U.S.-based team, overseeing CMC regulatory submissions, and interacting with health authorities. Candidates should have extensive experience in innovative drug development and direct regulatory CMC management, with a track record of leading health authority interactions and complex submissions. Collaboration with global cross-functional teams is crucial, along with strong interpersonal skills and the ability to influence decision-making.
Required Qualifications
- BA/BS Degree in scientific disciplines, MS/PhD preferred.
- 12+ years of relevant pharmaceutical or biopharmaceutical experience in innovative drug development, manufacturing, quality, or related CMC functions.
- At least 10 years of direct Regulatory CMC experience.
- Proven experience leading and developing teams of 10+ or more professionals in a global, matrixed environment.
- In-depth knowledge of ICH guidelines and global Regulatory CMC requirements.
Desired Qualifications
- Experience with gene therapy, cell therapy, and/or medical device–combination products.
- Familiarity with GMP and Quality Assurance regulations is a plus.
- Experience using Regulatory Information Management systems such as Veeva Vault is a plus.
- Multilingual capability is a plus.
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