Associate Director, Regulatory Affairs - CMC
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:
-
Pharmaceutical
Regulatory Compliance Specialist, Healthcare Compliance
Job Description & How to Apply Below
Associate Director, Regulatory Affairs - CMC, leading global regulatory strategy for small molecule drug development and registration.
Responsibilities- oversee preparation of CMC documentation for filings such as NDAs, INDs, and MAAs
- lead lifecycle management and post-approval change strategies
- collaborate cross-functionally with Regulatory Affairs, Technical Operations, and Quality teams
- manage agency interactions
- ensure compliance with global regulatory guidance and industry standards
- Bachelor's in a scientific discipline, 7-8+ years’ experience in Regulatory Affairs or CMC technical writing within pharma/biotech
- deep knowledge of small molecule development, GMP, ICH regulations, and global regulatory processes
- proven experience in preparing submissions and managing lifecycle changes
- strong collaboration, communication, and project management skills
- advanced degree (Masters or PhD)
- experience in non-ICH regions
- knowledge of regulatory aspects beyond CMC
- small molecules
- global regulatory environment
- lifecycle management
- IND/CTA/NDA/MAA submissions
- up to 20% travel
remote with up to 20% travel.
Position Requirements
10+ Years
work experience
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