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    Senior Director Compliance - United Kingdom - Gilead Sciences, Inc.

    Gilead Sciences, Inc.
    Gilead Sciences, Inc. United Kingdom

    1 week ago

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    Description
    Senior Director, CMC Regulatory Affairs Policy, Advisory, & Intelligence
    Senior Director, CMC Regulatory Affairs Policy, Advisory, & Intelligence
    United Kingdom - Uxbridge, United Kingdom - Cambridge Regulatory Regular Job Description

    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'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.

    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'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.

    The Senior Director, CMC Regulatory Affairs Policy, Advisory and Intelligence is a recognized expert both inside and outside the business, and is responsible for leading various aspects of internal and external-facing advocacy as applicable to support the Gilead portfolio.

    This leader will represent the business externally and will be focused on influencing while developing and advocating policy positions (internally and externally) for CMC regulatory issues in conjunction with the Gilead Quality Policy Office.

    The role will be focused on the European policy landscape and will be responsible for positioning Gilead's products/ portfolio for regulatory and technical success, contemporizing processes as needed, and supporting the holistic global harmonization of marketing applications.

    They will be accountable for consulting with project teams on the implementation of ICH and other appropriate technical regulations and guidelines.

    This position will require a strong and extensive external network as well as excellent communication and collaboration skills, as well as the ability to quickly digest, understand and communicate highly complex regulatory issues to a variety of stakeholders.

    The role will report directly to the Global Head of Policy, Advisory and Intelligence/CMC Regulatory Affairs.

    Serve as critical and recognized, internally and externally, thought leader and contributor to the CMC Regulatory Affairs Policy, Advisory, and Intelligence Office at Gilead Sciences.

    Lead development of Gilead's global CMC regulatory policies and priorities, with a focus on Europe-facing assets.

    Develop and implement solutions for global and far-reaching regulatory complexities and challenges, using a high degree of creativity, innovation and ingenuity.

    Present and articulate complex issues for resolution, communicating regularly with key stakeholders to ensure alignment, provide consultation as a scientific/technical resource within the department/cross-functional and therapeutic teams for assigned projects, mentor and share experience with colleagues.

    Facilitate and support project teams' identification of solutions for precedent-setting project issues and enable their understanding of local (European-facing) regulations and requirements.

    Build/maintain trust and establish a strong and effective network with relevant external partners, including global regulatory authorities, nonprofit organizations, and academic institutions, with specific focus on European health authorities and cross-industry associations.

    Matrix/coordinate/lead strategy development with Quality Policy-Intel group/ Gilead Policy.
    Develop and implement external strategies for Gilead's critical and precedent-setting initiatives (new technology, complex projects).

    Serve as the policy point of contact for select partners and stakeholders and communicate timely and relevant information/knowledge sharing.

    Independently lead key implementation efforts and highly significant projects to ensure Gilead's participation in multiple external forums addressing the development of global regulatory guidance.

    A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas

    Demonstrated track record in impacting global CMC regulatory affairs, developing innovative CMC regulatory strategies, and leadership in multiple international regulatory/industry forums for topics of external policy relevance.

    Strong knowledge of ICH guideline interpretation and implementation, previous ICH experience is highly preferred.
    Inclusion (Encouraging Diversity)

    Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

    In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact .

    YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
    We promote and support individual differences and diversity of thoughts and opinion.
    Full Time/Part Time Full-Time
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