Sr Manager, Regulatory Affairs at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

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
Significant regulatory, quality (preferred, based on incomplete text)

Responsibilities

Represents regional Regulatory Affairs or serves 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
Oversees and manages the work of less experienced colleagues supporting your work
Coaches and advises less experienced colleagues in completing their work and developing their regulatory capabilities

Skills

Regulatory Affairs

Regulatory Strategy

Regulatory Submissions

Virology

Cross-Functional Leadership

People Management

Coaching

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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