Role OverviewThe Regulatory Affairs Scientist will ensure compliance with FDA Sponsor responsibilities, serve as a subject matter expert for regulatory strategy, and provide support to integrated project teams and working groups. The role involves providing subject matter expertise on all regulatory matters related to assigned projects, ensuring ORA leadership and the sponsor's representative are kept current on the progress of the program, and leading the development of a written regulatory strategy.
What You Will Do
The main day-to-day responsibilities include providing regulatory support to an integrated product team or working group, attending meetings, updating ORA leadership and the sponsor's representative through routine reports, and creating or providing input to and maintaining Target Product Profiles.
Why It Might Be a Fit
The ideal candidate will have a strong understanding of regulatory affairs, excellent communication skills, and the ability to work effectively in a team environment. The role offers opportunities for growth and development, and the company values exceptional people, integrity, and inclusive collaboration.
Requirements
- U.S. Citizenship
- Current and unrestricted licensure and certifications
- Ability to obtain and maintain a government security clearance
- Willingness to comply with government vaccination requirements
Benefits
- Full benefit program
- Health insurance
- Paid time off (PTO)
- 401k with company contribution
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