Staff Regulatory Affairs Specialist, Pharmaceuticals (Remote)
Stryker(1 month ago)
About this role
A Staff Regulatory Affairs Specialist, Pharmaceuticals in the Endoscopy Division supporting pre-market regulatory activities for fluorescence imaging drug products used with endoscopy portfolios. The role is based in San Jose, CA or remote anywhere in the U.S. and interfaces with regulatory authorities to support product regulatory lifecycle and approvals.
Required Skills
- Regulatory Strategy
- Submission Preparation
- CTD Summaries
- Regulatory Assessment
- Project Management
- Scientific Writing
- Agency Communication
- Compliance
Qualifications
- Bachelor's Degree
- Bachelor's Degree in Health Science
- RAC Certification
- Masters in Regulatory Affairs
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