Manager, Regulatory Submission Management
Gilead Sciences
June 24, 2026
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Essential Duties and Job Functions:
- Execute independent, high-complexity global regulatory submissions (e.g., CSRs, investigator’s brochures, DSURs, regulatory responses, original INDs and amendments).
- Contribute to global submission content plans; lead review and planning for multiple products/projects.
- Represent RSM on cross-functional product/project/submission teams; provide specialist guidance on submissions requirements, timing, and speed-to-filing.
- Plan/oversee assigned deliverables, including global/regional content plans and resource planning; may serve as RSM lead for small–medium submissions.
- Act as SME for RSM core capabilities; support regulatory maintenance (early and late-stage products).
- Author submission documents (e.g., cover letters/forms) and contribute to submission standards/templates/validation decision trees.
- Interface with publishing team to plan/negotiage timelines and deliverables; oversee external contractors (where applicable).
- Ensure work complies with established practices/policies/processes and regulatory requirements.
People Leader Accountabilities:
- Create inclusion, develop talent, and empower teams.
Basic Qualifications:
- 6+ years with BS/BA; OR 4+ years with MS/MA.
Preferred Qualifications (selected):
- 6+ years relevant submission/ regulatory project management/operations in biopharma (or 4+ years with MS/MA/MBA; or 0 with PharmD/PhD).
- Strong biopharma submission experience across development stages; SME-level regulatory submission expertise; in-depth knowledge of health authorities and regulatory document requirements; strong analytical, communication, writing, project management, and tools (Microsoft Office, Smartsheet, SharePoint). Travel as needed.
Compensation/Benefits (included):
- Salary range: Other US Locations $123,930–$160,380; Bay Area $136,340–$176,440. May be eligible for annual bonus, long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions:
- Apply via the Internal Career Opportunities portal in Workday.
- Execute independent, high-complexity global regulatory submissions (e.g., CSRs, investigator’s brochures, DSURs, regulatory responses, original INDs and amendments).
- Contribute to global submission content plans; lead review and planning for multiple products/projects.
- Represent RSM on cross-functional product/project/submission teams; provide specialist guidance on submissions requirements, timing, and speed-to-filing.
- Plan/oversee assigned deliverables, including global/regional content plans and resource planning; may serve as RSM lead for small–medium submissions.
- Act as SME for RSM core capabilities; support regulatory maintenance (early and late-stage products).
- Author submission documents (e.g., cover letters/forms) and contribute to submission standards/templates/validation decision trees.
- Interface with publishing team to plan/negotiage timelines and deliverables; oversee external contractors (where applicable).
- Ensure work complies with established practices/policies/processes and regulatory requirements.
People Leader Accountabilities:
- Create inclusion, develop talent, and empower teams.
Basic Qualifications:
- 6+ years with BS/BA; OR 4+ years with MS/MA.
Preferred Qualifications (selected):
- 6+ years relevant submission/ regulatory project management/operations in biopharma (or 4+ years with MS/MA/MBA; or 0 with PharmD/PhD).
- Strong biopharma submission experience across development stages; SME-level regulatory submission expertise; in-depth knowledge of health authorities and regulatory document requirements; strong analytical, communication, writing, project management, and tools (Microsoft Office, Smartsheet, SharePoint). Travel as needed.
Compensation/Benefits (included):
- Salary range: Other US Locations $123,930–$160,380; Bay Area $136,340–$176,440. May be eligible for annual bonus, long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions:
- Apply via the Internal Career Opportunities portal in Workday.