• Job Description

  Req#: R0039435

  For Current Gilead Employees and Contractors:

  Please log onto your Internal Career Site to apply for this job.

  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.

  
  

  We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

  
  

  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. Join Gilead and help create possible, together.

  
  Job Description

  JOB TITLE – Associate Director, Global Regulatory Affairs Liaison - Virology

  FUNCTION: Global Therapeutic Area (TA) Regulatory Liaisons

  At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth, and retention of talent, and empower teams to align and achieve goals.

  This role can be based at our offices in Stockley Park or Cambridge in the UK.

  Job Description

  Global TA Regulatory Liaisons is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across drug discovery, development, and commercial teams. Global TA Regulatory Liaisons develop regulatory strategic options and work closely with cross-functional leaders and regulatory authorities to determine appropriate pathways to obtain and maintain licensure and optimal formulary listings. These strategies are essential in obtaining and maintaining licensure of Gilead's medicinal products and proprietary methodologies and technologies by managing registrations, other filings and regulatory agency communications and interactions in our key markets around the world.

  You may act as the Global Regulatory Lead for approved marketed established products or other programs. You may lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously and define the regulatory strategy, plans and objectives for assigned products or projects. You will oversee preparation and maintenance of regulatory submissions, regulatory labelling, 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.

  EXAMPLE 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 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.

  • 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 assigned products.

  • Critically reviews documents for submission to regulatory authorities.

  • May have one or more direct reports.

  • 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.

  • As needed, works with outsourcing Vendors to ensure outsourced work is completed to a high standard.

  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.

  Education & Experience

  BA/ BS or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research, or other related healthcare environment. Experience leading a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.

  Knowledge & Other Requirements

  • In-depth understanding of European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards for medicinal products. Understands varying regional or country regulatory requirements for assigned markets.

    • Strong knowledge of regulatory requirements and processes related to EU centralized procedure is desired.

    • Knowledge of EU national procedure a plus.

    • High level regulatory knowledge for rest of world markets a plus.

  • 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.

  The Gilead Difference

  Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. But it’s just what we do that gives us an edge, it’s how we do it. We expect everyone at Gilead to lead by example, guided by our core values:

  • Integrity (always doing the right thing)

  • Teamwork (collaborating in good faith)

  • Excellence (working at a high level of commitment and capability)

  • Accountability (taking personal responsibility)

  • Inclusion (encouraging diversity)

  
  

  Equal Employment Opportunity (EEO)

  It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

  
  For Current Gilead Employees and Contractors:

  Please log onto your Internal Career Site to apply for this job.

• About the company

  Gilead Sciences, Inc., is an American biopharmaceutical company headquartered in Foster City, California, that focuses on researching and developing antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

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