Associate Director, Regulatory Affairs

Associate Director, Regulatory Affairs - Virology At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID19 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 worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and were 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. 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 earlystage or other programs. You will lead Regulatory Submission Teams or other Regulatory Project Teams and represent Global Therapeutic Area Regulatory on crossfunctional core and subteams. You will typically serve as a Gilead contact to and 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. EXAMPLE RESPONSIBILITIES: As needed, represent Gilead in negotiations with regulatory authorities. Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities. Represent Regulatory Affairs and may serve as Regional Regulatory Lead or Global Regulatory Lead on crossfunctional/crossregional Regulatory Submission Teams; provide strategic advice and guidance to Regulatory Affairs and crossfunctional leaders and teams. May participate on other Subteams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their subteam participation. Define the regulatory strategy for multiple Gilead products or projects. Proactively identify regulatory or related risks/issues and develop mitigation and/or contingency plans. Oversee and guide the preparation, compilation and timely filing of regulatory submissions, requiring crossfunctional interactions for commercial or investigational products. Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendments and routine submissions (e.g., Development Safety Update Reports/DSURs, Investigator Brochure/IB updates, etc.). Oversee and approve the authoring of regulatory documents, including meeting requests, Module1 documents for original IND, etc. Oversee and guide labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets. Critically review documents for submission to regulatory authorities. Provide matrix management and leadership to project teams. Provide accurate and thorough input and recommendations into resource plans required to complete own deliverables. Track resources to ensure compliance with agreed resource allocation, including budgets. Ensure own work complies with established practices, policies and processes, and any regulatory or other requirements. REQUIREMENTS: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. 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 crossfunctional 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 Indepth 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. Indepth 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. Indepth 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 nonstandard negotiations. Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through postmarketing. 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. The salary range for this position is: Bay Area: $182,070.00 - $235,620.00. Other U.S. Locations: $165,495.00 - $214,170.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stockbased longterm incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include companysponsored medical, dental, vision, and life insurance plans.** Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For additional benefits information, visit: For jobs in the United States: 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, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status and other nonjob related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected under Section503 of the Rehabilitation Act of1973, the Vietnam Era Veterans Readjustment Act of1974 and TitleI of the Americans with Disabilities Act of1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT. YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT. #J-18808-Ljbffr