Regulatory Strategy Manager
Neurocrine Biosciences · San Diego
RegulatoryFull-time$133k–$182kCompany career page
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What they're looking for
- Bachelor's degree in life or health sciences plus 6+ years industry experience with minimum 3 years in regulatory affairs at research-based pharmaceutical company
- Master's degree in life or health sciences with 4+ years related experience, or PharmD/PhD with 2+ years experience
- Two years leading regulatory affairs in drug development
- Knowledge of FDA regulations and ICH guidelines for regulatory submissions
- Strong project management, verbal and written communication skills
- Ability to work independently and lead cross-functional teams with minimal direction
- Proficiency with computer systems and excellent analytical thinking abilities
What you'll be doing
- Develop, review, and file regulatory submissions including INDs, CTAs, DSURs, and annual reports
- Collaborate on global regulatory strategies supporting CMC, nonclinical, and clinical development programs
- Conduct regulatory intelligence research on competitive products and communicate emerging regulations to stakeholders
- Review clinical study documentation including protocols, informed consent forms, and recruitment materials
- Lead and coordinate preparation of regulatory filing documents with cross-functional project teams
Privacy & handoff
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