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Senior Associate, Regulatory Affairs
Job in
California, Moniteau County, Missouri, 65018, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Pharmaceutical
Healthcare Compliance -
Healthcare
Healthcare Compliance
Job Description & How to Apply Below
Role
Senior Associate Regulatory Affairs supporting global regulatory submissions and interactions at a biopharma focused on oncology therapeutics, specifically RAS-targeted inhibitors.
Responsibilities- coordinate and compile regulatory documentation aligned with ICH, FDA, and regional guidelines
- prepare routine submissions
- develop and implement SOPs for tracking product events
- assess regulatory backgrounds to inform development strategies
- stay updated on regulatory changes
- collaborate with multidisciplinary teams and represent Regulatory Affairs in project activities
- Bachelor's degree
- 4+ years of regulatory experience in drug/biologics companies
- familiarity with FDA regulations, ICH guidelines, and regulatory submission processes
- proficiency in MS Office, document management systems
- eager to develop further regulatory expertise
- oncology drug development experience
- experience with large, complex submissions like NDAs
- strong communication skills
Oncology focus, biologics/drugs, development stage not specified, emphasis on regulatory compliance, global submissions, and cross-functional collaboration.
Work Setupprimarily based in Redwood City, CA, salary range $120K-$150K, with considerations for local market; full-time, onsite.
Position Requirements
10+ Years
work experience
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