Global Therapeutic Area (TA) Regulatory Liaisons - Manager

Cambridge, England, United Kingdom

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, HealthcareIndustries

Requirements

Candidates should possess a Bachelor’s degree in a scientific discipline, such as Biology, Chemistry, or Pharmacy, with a strong preference for candidates holding a Master’s degree or PhD. Applicants must have at least 8 years of experience in regulatory affairs, with a minimum of 5 years specifically within the pharmaceutical industry, and demonstrated experience in the virology therapeutic area, particularly HIV, Hepatitis, and Emerging Viruses. Strong knowledge of global regulatory requirements, including those in Asia, Latin America, Africa, Eastern Europe, and the Middle East, is essential. Experience managing regulatory submissions and projects, and collaborating with cross-functional teams, is also required.

Responsibilities

As a Global Therapeutic Area (TA) Regulatory Liaison - Manager, you will be responsible for managing and leading regulatory strategies for designated products in the region, encompassing new product licenses and lifecycle activities. You will prepare and maintain regulatory submissions, regulatory labeling, and packaging for assigned products, guiding and advising colleagues on compliant completion of these activities. You will act as the Regional Regulatory Lead, partnering internally and externally with Gilead and other stakeholders to ensure successful regulatory outcomes. Furthermore, you will provide strategic and technical advice throughout the product lifecycle, representing the IC/GPS regulatory franchise on cross-functional teams.

Skills

Regulatory Strategy

Regulatory Submissions

HIV

Hepatitis

Emerging Viruses

Project Management

Cross-functional Team Collaboration

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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