Associate Director, Regulatory Affairs - Virology

Overview

Associate Director, Regulatory Affairs - Virology — Gilead Sciences

Join to apply for the Associate Director, Regulatory Affairs - Virology role at Gilead Sciences.

Responsibilities

As needed, represents Gilead in negotiations with regulatory authorities.

Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.

Represents Regulatory Affairs and may serve as Regional Regulatory Lead or Global Regulatory Lead on cross-functional / cross-regional Regulatory Submission Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.

May participate on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation.

Defines the regulatory strategy for multiple Gilead products or projects.

Proactively identifies regulatory or related risks / issues and develops mitigation and / or contingency plan.

Oversees and guides the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s).

Oversees and approves the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc.

Oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.

Critically reviews documents for submission to regulatory authorities.

Provides matrix management and leadership to project teams.

Provides accurate and thorough input and recommendations into resource plans required to complete deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.

Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

Qualifications

U.S. Education & Experience

• PharmD / PhD with 2+ years' relevant experience.
• MA / MS / MBA with 8+ years' relevant experience.
• BA / BS with 10+ years' relevant experience.

Significant regulatory, quality, compliance or related experience in the biopharma industry.

Proven track record in effectively setting and directing the regulatory or related strategy to successful conclusion for one or more products or key markets.

Experience and proven effectiveness working and negotiating with regulatory authorities.

Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.

Demonstrated abilities to effectively delegate and manage others, as evidenced through past matrix management responsibilities.

Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.

Knowledge & Other Requirements

In-depth understanding of FDA and EMA regulatory requirements and ICH standards for medicinal products. Understands varying regional or country regulatory requirements for assigned markets.

In-depth knowledge of current global and regional trends in biopharmaceutical regulatory affairs. Proven effectiveness applying this knowledge to optimize team deliverables and results.

Demonstrates advanced regulatory and business knowledge and analytical abilities, including assessing complex data and advising on regulatory implications.

In-depth knowledge of relevant health authorities, including past effectiveness in HA interactions.

Able to represent Gilead to regulatory authorities in standard and non-standard negotiations.

Thorough knowledge of the drug development process from early research through post-marketing.

Strong leadership presence with the ability to lead without authority and influence programs, projects and initiatives.

Strong interpersonal, communication and organizational skills.

Strong negotiation and conflict resolution skills.

Travel as needed.

Salary & Benefits

The Salary Range For This Position Is

Bay Area : $182,070.00 - $235,620.00.

Other US Locations : $165,495.00 - $214,170.00.

Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For Additional Benefits Information, Visit https : / / www.gilead.com / careers / compensation-benefits-and-wellbeing

Equal Employment Opportunity

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information or status protected by applicable laws.

Gilead provides a work environment free of harassment and supports individual differences and diversity of thought. Please apply via the Internal Career Opportunities portal in Workday if you are a current Gilead employee or contractor.

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