The Role
As a Senior Regulatory Affairs Scientist, you will develop submission strategies, prepare regulatory documents, and liaise with regulatory agencies for medical products.
Summary Generated by Built In
Description
Senior Regulatory Affairs Scientist
Location: Hybrid
Job Type: Full-Time
About the Role
Join a dynamic regulatory team as a Senior Regulatory Affairs Scientist, where you will lead submission strategies and regulatory interactions for innovative medical products.
Key Responsibilities
- Develop and execute regulatory strategies and submission plans
- Prepare and submit INDs, NDAs, BLAs, and IDEs
- Serve as primary liaison with FDA and regulatory agencies
- Provide regulatory guidance to cross-functional teams
- Monitor regulatory trends and ensure compliance with evolving requirements
- Review and approve regulatory documentation
Requirements
Qualifications
- Advanced degree in regulatory science, biology, or related field
- 8+ years of regulatory affairs experience
- Strong knowledge of FDA regulations and ICH guidelines
Preferred
- RAC certification
- Experience with electronic submissions (eCTD)
Skills Required
- Advanced degree in regulatory science, biology, or related field
- 8+ years of regulatory affairs experience
- Strong knowledge of FDA regulations and ICH guidelines
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The Company
What We Do
Venesco, LLC is a government contractor providing management consulting, IT, healthcare, research & development, and mission-critical services to federal agencies.
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