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Søborg

    Senior Director, Portfolio Regulatory Policy - Søborg, Danmark - Novo Nordisk A/S

    Novo Nordisk A/S
    Novo Nordisk A/S Søborg, Danmark

    for 1 uge siden

    Novo Nordisk A/S background
    Beskrivelse

    Are you passionate about shaping future regulatory frameworks and policies? Do you thrive in solving unique and complex problems that have a significant impact on the development of future medicines and devices? If so, we have an exciting opportunity for you to join our Global Regulatory Affairs Policy & Intelligence department at Novo Nordisk.

    Apply today for a life-changing career.

    The Position

    As a Senior Director for Portfolio Regulatory Policy, you will establish and manage a new team within the Global Regulatory Affairs Policy & Intelligence department which will focus on external policies and regulation that directly affect Novo Nordisk's product development portfolio. Examples of relevant topics to be covered include clinical trial innovation, digital health technology, data science and RWD/RWE, in addition to frameworks and guidelines specifically for development of new therapies (drugs and devices) falling within Novo Nordisk's therapeutic areas.

    Your key responsibilities are to:

    Manage the Portfolio Regulatory Policy team:

  • Lead the team to be a focused, engaged and high performing team managed in accordance with Novo Nordisk Way.
  • Line management of the individual employees in the team including supporting individual team members' development plans.
  • Strive for continuous improvement and simplification of processes and organisation set-up.
  • Responsibility for meeting the team's budget including preparation and follow-up, ensuring OHS for the area, and for the area's compliance with all applicable requirements and Business Ethics, etc.

    • Lead and set direction for regulatory policy activities and advocacy tasks to reach agreed goals:

  • Communication of new regulatory requirements, guidelines and trends, falling within the team's remit, to relevant RA product/development project teams and management teams.
  • Foreseeing and addressing complex issues of high importance to RA product/development project teams and the broader Novo Nordisk organisation, including driving analysis and putting into context the impact of new regulatory trends and requirements on Novo Nordisk business and regulatory strategies.
  • Identifying needs for policy advocacy activities.
  • Develop and execute appropriate external strategies with a view to influencing externally caused challenges that may impact the NN business.
  • Recommending appropriate internal process updates with a view to solving externally caused challenges that have impact on the NN business.
  • Support efforts to strengthen better practice sharing across the Novo Nordisk Global Regulatory Affairs product/development project teams and management teams.
  • Communicate and negotiate with external stakeholders including representing Novo Nordisk in external policy fora e.g. as NN's appointed member of relevant industry associations.
  • Present at external workshops, conferences and meetings with regulators and academia, etc.
  • Build external networks, and when relevant initiate external alliances and other relevant initiatives, to achieve goals within intelligence and policy workstreams.

    • You will report to the VP of GRA Policy & Intelligence (RP&I) and be part of the RP&I Leadership team.

    Qualifications

    To be successful in this role, you should have:

  • A relevant post-graduate degree, such as MSc or PhD, in pharma, science, healthcare, public health, policy, or law.
  • Deep knowledge of pharmaceutical regulatory affairs/regulatory science with 8-12 years of experience from the pharmaceutical industry, including preferably in a RA Policy and/or Intelligence department.
  • Proven ability to develop robust and successful regulatory policy positions and strategies for external engagement.
  • Experience from working with industry associations or other industry alliances.
  • People manager experience.
  • Excellent communication and leadership skills.
  • Strong business acumen and understanding of the pharmaceutical value chain.

    • About the Department

    Global Regulatory Affairs Policy & Intelligence ensures compliance with regulatory requirements and influences external regulatory frameworks. We combine scientific insight with the ability to navigate external agendas and stakeholders. Together with the Novo Nordisk Global Regulatory Affairs organisation and our network of RA colleagues in Novo Nordisk affiliates, we monitor new and developing regulations and, identify and assess emerging regulatory trends and issues. On that basis, we support Novo Nordisk's product development and life cycle management strategies, promoting overall regulatory excellence both internally and externally. We support the company's activities in a number of prioritised industry associations and other external fora where future requirements or implementation of current requirements are being discussed with regulators.

    Global Regulatory Affairs Policy & Intelligence is a hybrid team with members based in Denmark, Turkey, India, China, and the US.

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