Manager, Regulatory Submission Management
Gilead Sciences
June 24, 2026
Remote friendly (Parsippany, NJ)
United States
Operations
Job Description – Regulatory Submission Management (RSM)
Responsibilities
- Execute a wide range of regulatory submissions independently, including high-complexity submissions; contribute to global submission content plans.
- Lead review and planning processes for multiple products/projects; represent RSM on relevant product/project/regulatory submissions teams.
- Manage global submissions and oversee development/management of global and regional content plans and resource planning.
- Serve as a Subject Matter Expert (SME) for RSM core capabilities; support regulatory maintenance.
- Author and organize high-quality submission documents (e.g., cover letters, forms, procedures); develop/improve submission standards, templates, and validation decision trees.
- Interface with publishing team to plan/negotiate timelines and deliverables; oversee external contractors where applicable.
- Coach/train less-experienced RSM colleagues.
Basic Qualifications
- 6+ years with BS/BA OR 4+ years with MS/MA.
Preferred Qualifications / Skills
- 6+ years (or 4+ with MA/MS/MBA) submission management/regulatory project management/regulatory operations in biopharma; strong biopharma experience.
- Experience across multiple stages of drug development and multiple submission types; strong health authority/technical document knowledge.
- Fast learner; flexible/adaptable; strong analytical, attention-to-detail, communication/writing, project management; proficiency with Microsoft Office, Smartsheet, SharePoint; ability to lead/influence; matrix/team experience; travel when needed.
People Leader Accountabilities
- Create inclusion, develop talent, empower teams.
Benefits/Compensation (as stated)
- Salary range varies by location (Other US: $123,930–$160,380; Bay Area: $136,340–$176,440). May include annual bonus, stock-based incentives, paid time off, and medical/dental/vision/life insurance.
Application Instructions
- For current Gilead employees/contractors: apply via the Internal Career Opportunities portal in Workday.
Responsibilities
- Execute a wide range of regulatory submissions independently, including high-complexity submissions; contribute to global submission content plans.
- Lead review and planning processes for multiple products/projects; represent RSM on relevant product/project/regulatory submissions teams.
- Manage global submissions and oversee development/management of global and regional content plans and resource planning.
- Serve as a Subject Matter Expert (SME) for RSM core capabilities; support regulatory maintenance.
- Author and organize high-quality submission documents (e.g., cover letters, forms, procedures); develop/improve submission standards, templates, and validation decision trees.
- Interface with publishing team to plan/negotiate timelines and deliverables; oversee external contractors where applicable.
- Coach/train less-experienced RSM colleagues.
Basic Qualifications
- 6+ years with BS/BA OR 4+ years with MS/MA.
Preferred Qualifications / Skills
- 6+ years (or 4+ with MA/MS/MBA) submission management/regulatory project management/regulatory operations in biopharma; strong biopharma experience.
- Experience across multiple stages of drug development and multiple submission types; strong health authority/technical document knowledge.
- Fast learner; flexible/adaptable; strong analytical, attention-to-detail, communication/writing, project management; proficiency with Microsoft Office, Smartsheet, SharePoint; ability to lead/influence; matrix/team experience; travel when needed.
People Leader Accountabilities
- Create inclusion, develop talent, empower teams.
Benefits/Compensation (as stated)
- Salary range varies by location (Other US: $123,930–$160,380; Bay Area: $136,340–$176,440). May include annual bonus, stock-based incentives, paid time off, and medical/dental/vision/life insurance.
Application Instructions
- For current Gilead employees/contractors: apply via the Internal Career Opportunities portal in Workday.