Regulatory Strategy Manager
Neurocrine Biosciences
June 30, 2026
Remote friendly (San Diego, CA)
United States
Corporate Functions
About The Role
Responsible for supporting regulatory strategy execution for development programs. Works with the Director of Regulatory Affairs to prepare regulatory submissions (strategy, authoring, timeline planning) and maintain department regulatory processes. Coordinates and contributes to regulatory document packages for IND/CTA, NDA/BLA, DSUR/annual reports, clinical protocols, clinical study reports, application amendments, and postapproval activities. Ensures compliance with local/regional regulations, company policies, and internal quality/compliance standards. Provides regulatory representation on cross-functional teams, collaboratively develops regulatory strategies, performs regulatory review of clinical study documentation (protocols, informed consent documents, recruitment materials), and conducts regulatory research to communicate emerging regulations.
Your Contributions
- Develop, review, and/or file INDs/CTAs, briefing documents, and maintain development/approved applications; author DSURs, annual reports, and amendments
- Provide regulatory representation on cross-functional teams; support global regulatory strategy for CMC, nonclinical, and clinical activities
- Use regulatory intelligence to assess global strategies for relevant products/indications
- Develop and manage regulatory submission timelines
- Lead/coordinate/author/critically review regulatory filing documents; provide strategic input
- Review clinical documentation (protocols, informed consent, recruitment materials)
- Conduct regulatory research and recommend actions regarding new/emerging regulations
- Develop and maintain SOPs and department working practices
Requirements
- BS/BA in Life/Health Sciences AND 6+ years industry experience (min 3 years Regulatory Affairs in drug development; 2 years lead capacity), including FDA regulations and ICH guidelines
OR Master’s (preferred) AND 4+ years related experience
OR PharmD/PhD AND 2+ years related experience
Skills
- Best practices in regulatory discipline; improved tools/processes
- Lead multiple teams; leadership, communication, problem-solving, analytical thinking, project management
- Independent work with minimal direction; strong computer skills
Benefits
- Annual bonus (target 30% of earned base), equity long-term incentive eligibility; retirement plan (match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription, dental, vision)
Responsible for supporting regulatory strategy execution for development programs. Works with the Director of Regulatory Affairs to prepare regulatory submissions (strategy, authoring, timeline planning) and maintain department regulatory processes. Coordinates and contributes to regulatory document packages for IND/CTA, NDA/BLA, DSUR/annual reports, clinical protocols, clinical study reports, application amendments, and postapproval activities. Ensures compliance with local/regional regulations, company policies, and internal quality/compliance standards. Provides regulatory representation on cross-functional teams, collaboratively develops regulatory strategies, performs regulatory review of clinical study documentation (protocols, informed consent documents, recruitment materials), and conducts regulatory research to communicate emerging regulations.
Your Contributions
- Develop, review, and/or file INDs/CTAs, briefing documents, and maintain development/approved applications; author DSURs, annual reports, and amendments
- Provide regulatory representation on cross-functional teams; support global regulatory strategy for CMC, nonclinical, and clinical activities
- Use regulatory intelligence to assess global strategies for relevant products/indications
- Develop and manage regulatory submission timelines
- Lead/coordinate/author/critically review regulatory filing documents; provide strategic input
- Review clinical documentation (protocols, informed consent, recruitment materials)
- Conduct regulatory research and recommend actions regarding new/emerging regulations
- Develop and maintain SOPs and department working practices
Requirements
- BS/BA in Life/Health Sciences AND 6+ years industry experience (min 3 years Regulatory Affairs in drug development; 2 years lead capacity), including FDA regulations and ICH guidelines
OR Master’s (preferred) AND 4+ years related experience
OR PharmD/PhD AND 2+ years related experience
Skills
- Best practices in regulatory discipline; improved tools/processes
- Lead multiple teams; leadership, communication, problem-solving, analytical thinking, project management
- Independent work with minimal direction; strong computer skills
Benefits
- Annual bonus (target 30% of earned base), equity long-term incentive eligibility; retirement plan (match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription, dental, vision)