Senior Director, Portfolio Regulatory Policy

Job title:

Senior Director, Portfolio Regulatory Policy

Company:

Novo Nordisk

Job description

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 PositionAs 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 patient centric regulatory policies that directly affect Novo Nordisk’s product portfolio. Examples of relevant topics to be covered include innovation in clinical trials, 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:

• Setting direction for the team and leading it 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.
• 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, both internally and externally:

• Communicating 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 the broader Novo Nordisk organisation, including driving the analysis and putting into context the impact of new regulatory trends and requirements on Novo Nordisk business and regulatory strategies.
• Recommending appropriate internal process updates with a view to solving externally caused challenges that have impact on the NN business.
• Recommending appropriate external strategies with a view to influencing externally caused challenges that may impact the NN business.
• Identifying needs for policy advocacy activities and leading and managing regulatory activities and advocacy activities to reach agreed goals.
• Supporting efforts to strengthen better practice sharing across the Novo Nordisk Global Regulatory Affairs product/development project teams and management teams.
• Communicating and negotiating with external stakeholders including representing Novo Nordisk in external policy fora e.g. as NN’s appointed member of relevant industry association committees.
• Presenting at external workshops, conferences and meetings with regulators and academia, etc.

• As relevant, building 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.QualificationsTo be successful in this role, you should have:

• Deep knowledge of pharmaceutical regulatory affairs/regulatory science, preferably with hands-on experience from the European Union. Additional other regions are a plus.
• First line people manager experience.
• 8-12 years of experience from the pharmaceutical industry, preferably in a RA Policy/Intelligence department.
• Proven ability to develop robust and successful regulatory policy positions and strategies.

Experience from industry associations.

• Excellent communication and leadership skills.
• Strong business acumen and understanding of the pharmaceutical value chain.
• A relevant post-graduate degree, such as MSc or PhD, in pharma, science, healthcare, public health, policy, or law.

About the DepartmentGlobal 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 Søborg – Denmark, Istanbul – Turkey, Bangalore – India, Tianjin – China, and Washington DC – US.Working at Novo NordiskNovo Nordisk 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 DeadlineFor further information, please contact Ane Sofie Böhm Nielsen on +45 3075 5326.Apply by 11 April 2024.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At Novo Nordisk 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.

Expected salary

Location

Søborg, Hovedstaden

Job date

Thu, 28 Mar 2024 23:49:13 GMT

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