Senior Director, Portfolio Regulatory Policy

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Søborg

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 [xxxxx]. 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 [xxxxx]’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 [xxxxx] 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 [xxxxx] organisation, including driving analysis and putting into context the impact of new regulatory trends and requirements on [xxxxx] 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 [xxxxx] Global Regulatory Affairs product/development project teams and management teams.
  • Communicate and negotiate with external stakeholders including representing [xxxxx] 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 [xxxxx] Global Regulatory Affairs organisation and our network of RA colleagues in [xxxxx] affiliates, we monitor new and developing regulations and, identify and assess emerging regulatory trends and issues. On that basis, we support [xxxxx]’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. Working at [xxxxx] [xxxxx] is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 61,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing. Contact and Deadline For further information, please contact Ane Sofie Böhm Nielsen on +[xxxxx]. Apply by 21 May 2024. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


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    Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 30.1.2024, men kan have været deaktiveret og genaktiveret igen.

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