Associate Director, Regulatory Affairs - Virology

Gilead Sciences, Inc.•Parsippany, NJ

67d•$165,495 - $235,620

About The Position

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description As an Associate Director, Global Regulatory Affairs, you will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the virology therapeutic area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submission Teams or other Regulatory Project Teams and represent Global Therapeutic Area Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will also play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. Position will be filled in either Foster City, CA or Parsippany, NJ.

Requirements

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.
In-depth understanding of U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use 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 advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on its regulatory implications.
In-depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
Able to represent Gilead to regulatory authorities when managing standard and non-standard negotiations.
Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills.
Strong negotiation and conflict resolution skills.
When needed, ability to travel.

Nice To Haves

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

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). Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendment, and routine submissions (e.g., Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.).
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 own 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.

Benefits

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

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