Associate Director, Regulatory Submission Management
Gilead Sciences
September 03, 2026
On-site
San Francisco Bay Area
Corporate Functions
Associate Director, Regulatory Submission Management (RSM)
Responsibilities:
- Direct planning and execution of regulatory programs/submission activities for highly complex global submissions and initiatives.
- Partner with RA Liaisons and GRAD to create global filing plans and maintain program-level timelines with regulatory milestones.
- May lead regulatory portfolio planning as needed.
- Lead/coordinate moderately complex project communications; plan and conduct submission team meetings; anticipate obstacles and develop solutions.
- Facilitate cross-functional communication across Regulatory Affairs (e.g., Labeling, Advertising/Promotion, Innovation, IDEP, Medical Writing, Regulatory CMC) and other functional partners.
- Support RSM across programs/projects; attend sub-team meetings; organize ad hoc working groups.
- Initiate/contribute to local and global process improvements.
- Manage 2–4 major submissions (e.g., NDA, MAA, BLA, sNDAs/T2Vs, IND, RtQs).
- Coordinate/track submission project information (minutes, timelines, action items, deliverables) and ensure integration of timing, scope, and resources.
- Organize/lead high-quality documents for internal/external stakeholders; act as subject area expert.
- Ensure submissions comply with global health authority requirements and ICH/local/regional requirements and company policies.
Qualifications:
- Basic: 10+ years with BS/BA OR 8+ years with MS/MA or MBA.
Preferred:
- 10+ years relevant submission management/regulatory project management/operations experience (biopharma); or 8+ years with MA/MS/MBA; or 5+ years with PharmD/PhD.
- Proven ability managing submission teams; strong negotiation/conflict resolution; track record managing multiple submissions.
- Knowledge of drugs/biologics development and regional requirements (e.g., US/EU); functional/therapeutic area expertise.
- Mentorship/leading in matrixed environments; PMP or other PM certification (plus); Agile knowledge (plus).
- Advanced submission management tools/reporting skills (e.g., Veeva, Docubridge, Smartsheet, Planisware, MS Project).
- Ability to travel as needed.
People Leader Accountabilities:
- Create inclusion; develop talent; empower teams.
Compensation/Benefits (if stated): $182,070.00–$235,620.00 base salary; may be eligible for discretionary bonus, stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life.
Application instructions:
- Apply via the Internal Career Opportunities portal in Workday (for current Gilead employees/contractors).
Responsibilities:
- Direct planning and execution of regulatory programs/submission activities for highly complex global submissions and initiatives.
- Partner with RA Liaisons and GRAD to create global filing plans and maintain program-level timelines with regulatory milestones.
- May lead regulatory portfolio planning as needed.
- Lead/coordinate moderately complex project communications; plan and conduct submission team meetings; anticipate obstacles and develop solutions.
- Facilitate cross-functional communication across Regulatory Affairs (e.g., Labeling, Advertising/Promotion, Innovation, IDEP, Medical Writing, Regulatory CMC) and other functional partners.
- Support RSM across programs/projects; attend sub-team meetings; organize ad hoc working groups.
- Initiate/contribute to local and global process improvements.
- Manage 2–4 major submissions (e.g., NDA, MAA, BLA, sNDAs/T2Vs, IND, RtQs).
- Coordinate/track submission project information (minutes, timelines, action items, deliverables) and ensure integration of timing, scope, and resources.
- Organize/lead high-quality documents for internal/external stakeholders; act as subject area expert.
- Ensure submissions comply with global health authority requirements and ICH/local/regional requirements and company policies.
Qualifications:
- Basic: 10+ years with BS/BA OR 8+ years with MS/MA or MBA.
Preferred:
- 10+ years relevant submission management/regulatory project management/operations experience (biopharma); or 8+ years with MA/MS/MBA; or 5+ years with PharmD/PhD.
- Proven ability managing submission teams; strong negotiation/conflict resolution; track record managing multiple submissions.
- Knowledge of drugs/biologics development and regional requirements (e.g., US/EU); functional/therapeutic area expertise.
- Mentorship/leading in matrixed environments; PMP or other PM certification (plus); Agile knowledge (plus).
- Advanced submission management tools/reporting skills (e.g., Veeva, Docubridge, Smartsheet, Planisware, MS Project).
- Ability to travel as needed.
People Leader Accountabilities:
- Create inclusion; develop talent; empower teams.
Compensation/Benefits (if stated): $182,070.00–$235,620.00 base salary; may be eligible for discretionary bonus, stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life.
Application instructions:
- Apply via the Internal Career Opportunities portal in Workday (for current Gilead employees/contractors).