Director of Regulatory Affairs
Job Summary
Client-facing and strategic, the full-time salaried Director of Regulatory Affairs will provide regulatory consulting, prepare documentation for submissions, and interact with clients and health authorities in a fully remote capacity.
Key responsibilities
- Provide strategic advice to clients from early development through NDA/BLA submission
- Independently prepare regulatory documentation, including US IND and NDA/BLA modules
- Lead interactions with clients and FDA, serving as the primary point of contact for health authorities
Required qualifications
- Bachelor's degree in science, toxicology, pharmacology, engineering, or a related field; advanced degree preferred
- 10 years of relevant experience in a CRO or pharmaceutical company, with at least 5 years in regulatory development leadership
- Thorough knowledge of ICH GCP guidelines and regulatory requirements for clinical trials
- Demonstrated ability to lead teams and manage regulatory obligations effectively
- Proficiency in Microsoft Word and Excel, with the ability to learn new software applications
Complete Job Description
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