Associate Director, Regulatory Affairs - Virology 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

Act as the Regional Regulatory Lead on complex or multiple products, compounds, indications, or projects in the virology therapeutic area
Manage and oversee multiple products or projects simultaneously
Serve as Global Regulatory Lead for early-stage or other programs
Lead Regulatory Submission Teams or other Regulatory Project Teams
Represent Global Therapeutic Area Regulatory on cross-functional core and sub-teams
Serve as Gilead contact to/for regulatory authorities
Oversee preparation and maintenance of regulatory submissions, regulatory labeling, and packaging for assigned products or projects
Guide and advise colleagues in thorough and compliant completion of regulatory activities
Play a leadership role in ad hoc or special projects to improve or advance Regulatory Affairs capabilities
Be available to work in either Foster City, CA or Parsippany, NJ

Responsibilities

Represent Gilead in negotiations with regulatory authorities as needed
Make significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies, and capabilities
Represent Regulatory Affairs and serve as Regional Regulatory Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams
Provide strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams
Participate on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign and oversee colleagues' participation
Define the regulatory strategy for multiple Gilead products or projects
Proactively identify regulatory or related risks/issues and develop mitigation and/or contingency plans
Oversee and guide the preparation, compilation, and timely filing of regulatory submissions requiring cross-functional interactions (e.g., meeting requests, briefing packages, original IND, IND amendments, DSURs, IB updates)
Oversee and approve the authoring of regulatory documents (e.g., meeting requests, Module 1 documents for original IND)
Oversee and guide labeling, packaging, and associated information updates and maintenance in accordance with the product license for assigned products and markets
Critically review documents for submission

Skills

Regulatory Affairs

Virology

Regulatory Strategy

Regulatory Submissions

Project Team Leadership

Cross-functional Collaboration

Regulatory Authorities Interaction

Global Regulatory Affairs

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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