Gilead Sciences

Global Therapeutic Area (TA) Regulatory Liaisons – Associate Director

Cambridge, England, United Kingdom

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries

Requirements

The Associate Director, Global Therapeutic Area (TA) Regulatory Liaisons should have experience in regulatory affairs, specifically within the Virology therapeutic area, and be responsible for supporting Gilead's strategic decisions for patient access to molecules. The role requires expertise in managing complex regulatory strategies, submissions, and lifecycle activities for products across the Intercontinental and Gilead Patient Solutions region, including Asia, Latin America, Africa, Eastern Europe, and the Middle East. Experience with HIV, Hepatitis, and/or Emerging Viruses projects is essential, along with a strong understanding of regulatory submissions and compliance.

Responsibilities

The Associate Director will act as the Regional Regulatory Lead, overseeing and managing regulatory strategies for one or multiple products in the Virology TA. Responsibilities include shaping regulatory strategy, plans, and objectives, managing regulatory submissions and projects, and representing the regulatory affairs team on cross-functional teams. The role involves providing strategic and technical advice throughout the product lifecycle, overseeing the preparation and maintenance of regulatory submissions and labeling, and contributing to the development of regulatory strategies, processes, and capabilities. The Associate Director will also partner with internal regulatory affairs and cross-functional teams to ensure effective execution of regulatory strategies and build strong relationships.

Skills

Regulatory Strategy
Regulatory Submissions
Project Management
Virology
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.

Land your dream remote job 3x faster with AI