Associate Director, Regulatory Affairs – Virology | Parsippany, New Jersey, United States
Department: Regulatory Affairs
Employment Type: Full-Time
Location: Onsite / Hybrid Eligible
Company Overview:
Gilead Sciences is a global biopharmaceutical leader dedicated to improving patient outcomes and advancing healthcare worldwide. For over 35 years, Gilead has developed transformative therapies for HIV, viral hepatitis, COVID-19, and cancer, ensuring patients have access to life-changing medicines.
Position Overview:
Gilead Sciences is seeking an experienced Associate Director in Regulatory Affairs – Virology to serve as the Regional or Global Regulatory Lead for complex virology products, compounds, and projects. This role provides strategic leadership, regulatory guidance, and oversight across multiple products or indications. The Associate Director will manage regulatory submissions, labeling, and packaging, while liaising with regulatory authorities to ensure compliance and facilitate approvals.
Key Responsibilities:
Lead and define regulatory strategy, objectives, and plans for multiple virology products or projects.
Represent Gilead in interactions and negotiations with regulatory authorities, including the FDA, EMA, and other global health agencies.
Serve as the Regional or Global Regulatory Lead on cross-functional Regulatory Submission Teams, ensuring alignment with global and local strategies.
Oversee preparation, review, and submission of regulatory documents, including INDs, amendments, DSURs, Investigator Brochures, labeling, and packaging updates.
Provide strategic guidance to regulatory and cross-functional teams, mitigating risks and ensuring compliance.
Participate in or oversee sub-teams (clinical, nonclinical, biomarkers, study management) and guide team members in regulatory tasks.
Track and manage resources, budgets, and timelines for regulatory deliverables.
Lead or contribute to special projects that enhance Regulatory Affairs capabilities and efficiencies.
Experience & Qualifications:
PharmD/PhD: 2+ years relevant regulatory experience in biopharma.
MA/MS/MBA: 8+ years relevant regulatory experience.
BA/BS: 10+ years relevant regulatory experience.
Proven experience in regulatory strategy, submissions, and interactions with health authorities.
Demonstrated success in cross-functional team leadership and matrix management.
In-depth knowledge of U.S. FDA, EMA, and ICH guidelines, with understanding of regional or country-specific requirements.
Strong analytical skills with the ability to assess complex scientific and regulatory data.
Excellent communication, negotiation, and conflict resolution skills.
Experience in virology therapeutic areas and various stages of drug development preferred.
Ability to travel as needed.
People Leadership Responsibilities:
Create Inclusion: Foster diverse and inclusive teams, embedding the value of diversity in management practices.
Develop Talent: Coach and mentor employees to support career growth and maximize performance potential.
Empower Teams: Align team goals with organizational objectives, remove barriers, and ensure accountability.
Compensation & Benefits:
Salary Range: $165,495 – $214,170 (Other US Locations); $182,070 – $235,620 (Bay Area)
Eligible for discretionary annual bonus, stock-based incentives, paid time off, and comprehensive benefits including medical, dental, vision, and life insurance.
Equal Opportunity Employer:
Gilead Sciences is committed to a diverse and inclusive work environment. Reasonable accommodations are available for applicants with disabilities.
Job Requisition ID: R0048015
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