Manager, Regulatory Affairs
$116,000–$160,000 year
HybridWaltham, Massachusetts, United States
Job Summary
Prepare, review, and submit regulatory filings including INDs/CTAs, amendments, and Investigator's Brochures while coordinating global health authority meeting documents. Contribute to global regulatory strategy for early- and late-stage development programs, ensuring submissions meet quality standards and health authority requirements. Represent regulatory interests in study-level activities covering start-up, maintenance, and end-of-trial processes. Collaborate with external partners and vendors on submission support and lead regulatory operations initiatives, including work instruction and SOP development. Manage multiple priorities in a fast-paced environment with strong cross-functional collaboration.
Required Qualifications
- Bachelor's degree, preferably in a scientific discipline
- 6+ years of pharmaceutical industry experience
- 4+ years in Regulatory Affairs
- Strong knowledge of U.S. and international regulatory requirements for drug development
- Excellent verbal and written communication skills
- Organizational skills
- Cross-functional collaboration skills
- Ability to work in a self-motivated, fast-paced environment
Desired Qualifications
- Experience supporting initial INDs/CTAs
- Experience supporting initial marketing application activities
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