Director, Regulatory Affairs Advertising and Promotion

United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

The Director, Regulatory Affairs Advertising and Promotion should possess a Bachelor’s degree in a relevant scientific or regulatory field, and have at least 10 years of experience in regulatory affairs, with a strong focus on advertising and promotion of pharmaceutical products, and preferably experience in the biotechnology or pharmaceutical industry. Demonstrated leadership experience and the ability to manage and develop a team are also required.

Responsibilities

This role involves managing the commercial regulatory strategy and execution for multiple brands, providing strategic regulatory guidance on new concepts and campaigns, reviewing and approving promotional materials, serving as PRC Chair for complex brands, maintaining awareness of FDA regulations and enforcement actions, representing Gilead’s commercial activities to regulatory agencies, leading process improvements, and advising cross-functional stakeholders on regulatory impact. The position also includes managing direct reports, setting goals, coaching team members, and potentially leading special projects.

Skills

Regulatory Affairs

Advertising and Promotion

Regulatory Guidance

Compliance

Cross-functional Collaboration

Strategic Planning

Regulatory Strategy

Regulatory Submissions

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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