Senior Regulatory Affairs Scientist
On-siteFrederick, Maryland, United States
Frederick, Maryland, United StatesOn-siteFull TimeSenior LevelDoctorate Or Professional DegreeMedium
Full TimeSenior LevelDoctorate Or Professional DegreeMedium
Job Summary
Develop regulatory pathways and approval strategies while leading preparation and review of FDA submissions. Serve as regulatory lead for assigned programs, providing risk assessments and mitigation strategies for the medical product lifecycle. Support FDA meetings and agency interactions, create and maintain Target Product Profiles, and monitor regulatory intelligence. Review product development documentation and mentor junior regulatory personnel. Lead SOP and process improvement initiatives to ensure compliance throughout the entire lifecycle.
Required Qualifications
- Master's degree or higher in Life Sciences, Pharmacy, Regulatory Affairs, or related field
- Regulatory Affairs Certification (RAC)
- Minimum 12 years of FDA regulatory affairs experience
- Extensive experience preparing INDs, NDAs, BLAs, IDEs, and 510(k) submissions
- Experience interacting directly with FDA review divisions
- Strong leadership and mentoring experience
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