Gilead Sciences

Associate Director, Regulatory Affairs Advertising and Promotion

United States

Gilead Sciences Logo
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries

Requirements

Candidates should possess a Bachelor’s degree in a scientific discipline, such as Pharmacy, Biology, Chemistry, or a related field, and hold a minimum of 8 years of experience in regulatory affairs, with at least 5 years in advertising and promotion, preferably within the pharmaceutical industry. Strong knowledge of FDA regulations, guidelines, and enforcement actions related to pharmaceutical advertising and promotion is essential, as is experience with Promotional Review Committee (PRC) processes. Demonstrated ability to manage complex regulatory interactions and provide strategic guidance is required, along with experience in leading cross-functional teams and mentoring junior colleagues.

Responsibilities

The Associate Director, Regulatory Affairs Advertising and Promotion will manage the commercial regulatory strategy and execution for assigned brands or therapeutic areas, providing strategic regulatory guidance and input on Gilead’s commercial and corporate communications. They will serve as PRC Chair for complex brands, review and approve promotional materials, maintain awareness of FDA regulations and guidance, represent Gilead’s commercial regulatory perspective to regulatory agencies, lead local process improvements, provide regulatory guidance on new marketing concepts, and communicate relevant updates to cross-functional teams. Additionally, the role involves mentoring RA Ad/Promo and cross-functional team members, and potentially managing direct reports.

Skills

Regulatory Affairs
Advertising and Promotion
Regulatory Guidance
Compliance
Cross-functional Collaboration
Strategic Planning
Regulatory Strategy Execution

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.

Key Metrics

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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