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Director of Regulatory Affairs
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist -
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
Regulatory Affairs Director overseeing global regulatory strategies and submissions, including the upcoming NDA filing.
Responsibilities- manage and execute high-quality regulatory submissions
- perform detailed document review and quality control
- maintain regulatory records
- coordinate with cross-functional teams
- develop and support regulatory strategies for clinical and manufacturing programs
- contribute to labeling and inspection readiness
- oversee external vendors
- Bachelor's in a scientific discipline with 8+ years in pharma/biotech, including 6+ years in Regulatory Affairs
- hands-on experience with NDA/BLA/MAA submissions and electronic submissions (eCTD)
- deep knowledge of FDA and ICH regulations
- familiarity with GMP, GCP, GLP
- experience supporting regulatory interactions and working with CROs/CMOs
- advanced degree (MS, PhD, PharmD)
- RAC certification
- experience in metabolic/endocrine/cardiometabolic areas
- drug-device combination products
- knowledge of digital publishing tools
- NDA filing
- regulatory strategy
- eCTD
- cross-functional collaboration
- global regulatory standards
- small to mid-size sponsor environment
- remote working at San Diego headquarters
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