Gilead Sciences · 2 weeks ago
Sr Manager, Regulatory Affairs - Virology
San Francisco Bay Area
Full-time
Onsite
Senior Level
$158K/yr - $204K/yr
6+ years expGilead Sciences is committed to creating a healthier world by tackling significant diseases such as HIV and COVID-19. The Sr Manager, Regulatory Affairs in Virology will lead regulatory strategies and submissions, ensuring compliance and managing cross-functional teams while supporting the development of life-changing therapies.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams
Participates on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers)
With guidance, defines the regulatory strategy for one or more Gilead products or projects
Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans
Leads the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendment, and routine submissions (e.g., Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.)
Leads cross-functional teams in the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc
Provides input to the content of the original label and label updates
Ensures product packaging and associated information is updated and maintained in accordance with the product license for assigned products and markets
Critically reviews documents for submission to regulatory authorities
Initiates or otherwise contributes to process improvements and/or other special projects within Regulatory Affairs
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements
Qualification
Required
Doctorate and 2+ years of relevant experience OR
Master's and 6+ years of relevant experience OR
Bachelor's and 8+ years of relevant experience OR
Preferred
Significant regulatory, quality, compliance or related experience supporting medicinal products
Significant regulatory experience in the biopharma industry is strongly preferred
Experience setting the regulatory strategy and leading regulatory submissions and other activities for a medicinal product is strongly preferred
Experience successfully leading departmental and cross-functional teams without authority
Experience authoring and implementing processes
Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred
Demonstrated ability to be a fast learner
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed
Demonstrates advanced knowledge of regulatory requirements and the role of regulatory affairs in achieving cross-functional drug discovery and development goals and objectives, including ICH standards and the regulatory requirements for assigned markets
In-depth knowledge of relevant health authorities, including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions
Able to represent Gilead to regulatory authorities when managing standard or more routine negotiations
Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles
Ability to lead and influence programs, projects and/or initiatives
Strong interpersonal skills and understanding of team dynamics
Proven ability to work successfully in a team-oriented, highly-matrixed environment
When needed, ability to travel
Benefits
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-16
FierceBiotech
2026-01-16
Company data provided by crunchbase