Current jobs related to Regulatory Affairs Lead - Gladsaxe Kommune - Novo Nordisk AS


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job DescriptionThis position plays a critical role in shaping the future of our Diabetes area in Global Regulatory Affairs.As a Manager in Regulatory Affairs Diabetes, you will lead a diverse team consisting of global regulatory leads, specialists, and regulatory professionals. You will report to the Director of Regulatory Affairs Diabetes and be part of a...


  • Gladsaxe, Gladsaxe Municipality, Denmark Kenvue Full time

    Job OverviewKenvue seeks a seasoned Regulatory Affairs Specialist to spearhead compliance and regulatory approvals for new products, line extensions, and additional claims.This critical role involves managing the coordination and submission of regulatory applications for drugs, cosmetics, medical devices, and similar products to ensure a smooth approval...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Role OverviewAs a Regulatory Affairs Manager in our Diabetes area, you will be responsible for leading a diverse team of regulatory professionals. You will develop and implement strategic plans to achieve business objectives and collaborate with cross-functional teams to drive regulatory strategies.Key responsibilities include:Leading and managing a...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Strategist to join our team at Novo Nordisk A/S. In this role, you will provide strategic, tactical, and operational regulatory input to projects, leading activities for synthetic small molecule projects in late development.As a key member of our RA CMC Synthetics & Cell Technologies...


  • Gladsaxe, Gladsaxe Municipality, Denmark Kenvue Full time

    Kenvue is a leading global healthcare company seeking a skilled Regulatory Affairs Professional to join our team in Helsingborg, Sweden.The ideal candidate will have 6+ years of related regulatory experience and a solid understanding of regulatory/medical/safety/quality requirements in markets of relevance.Key responsibilities include:Managing the...


  • Gladsaxe Kommune, Denmark Novo Nordisk AS Full time

    Select how often (in days) to receive an alert: Create Alert Regulatory Affairs Manager, Diabetes Area Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Are you a natural leader who drives ambitious goals, sets direction, and drives success via empowerment? Do you gain energy from supporting individual...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About Us">At Novo Nordisk, we are driven by a shared purpose: to prevent chronic diseases and improve the lives of people with diabetes. Our team in RA CagriSema T2D & Amplify is committed to developing innovative treatment options for patients worldwide.">The Role">We are seeking an experienced Regulatory Affairs Lead to join our late-stage development...


  • Gladsaxe, Gladsaxe Municipality, Denmark Kenvue Full time

    Kenvue, a leading consumer healthcare company, is seeking a skilled Senior Regulatory Affairs Specialist to join our team in Helsingborg, Sweden.The ideal candidate will have expertise across a broad spectrum of regulatory classifications, including Medicinal Products, Cosmetics, Commodities, and/or Medical Devices. They will provide regulatory input and...


  • Gladsaxe, Gladsaxe Municipality, Denmark Reckitt Benckiser Full time

    Reckitt Benckiser, a global leader in consumer goods, is seeking a highly skilled Regulatory Affairs Specialist to join our dynamic team. As a key member of our regulatory affairs function, you will be responsible for ensuring ongoing compliance with regulations and product safety standards across Nordic markets.The ideal candidate will possess a deep...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Join Our TeamNovo Nordisk A/S is committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in.As a Clinical Outcome Assessment Specialist, you will be part of a dynamic and collaborative team that is dedicated to driving change in healthcare.Key ResponsibilitiesYou will be...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleNovo Nordisk is seeking an experienced Regulatory Affairs Manager to lead our Diabetes area in Global Regulatory Affairs. This is a unique opportunity to make a meaningful impact on our company's success and shape the future of our industry.As a key member of our leadership team, you will play a critical role in developing and implementing...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job SummaryThis role will lead a diverse team consisting of global regulatory leads, specialists, and regulatory professionals in the Diabetes area. The successful candidate will be responsible for managing day-to-day operations, aligning team skills with company ambitions, and ensuring employee development.The ideal candidate will have a master's degree in...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    We are expanding our product and project pipeline in Novo Nordisk, seeking an engaged Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) specialist with expertise in synthetic small molecules to join the Synthetics & Cell Technologies Department in the RA CMC Biotech & Rare Disease area.The RoleProvide strategic, tactical, and operational...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Company OverviewNovo Nordisk A/S is a global leader in the development of innovative treatments for chronic diseases. Our team is committed to delivering high-quality solutions that meet the evolving needs of patients, healthcare professionals, and payers.About the DepartmentOur Regulatory Affairs department plays a critical role in ensuring compliance with...


  • Ballerup Kommune, Denmark Viatris Full time

    Regulatory Affairs Specialist Regulatory Affairs Specialist Apply locations: Ballerup, Capital, Denmark Time type: Full time Posted on: Posted Yesterday Job requisition id: R5656408 At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare...


  • Aarhus kommune, Denmark Arla Foods Deutschland GmbH Full time

    Are you our new Regulatory Affairs Specialist, with passion and skills to work with dairy ingredient manufacturing on a global agenda? Are you ready to take up an important role in a global organisation marked by entrepreneurial spirit, a strong innovation pipeline and substantial growth? Then this is your chance to join a fantastic department of Global...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking an experienced Regulatory Affairs Professional to join our team for a 12-month maternity cover.Main Responsibilities:Contribute regulatory expertise to global strategies, driving several tasks with challenging and often overlapping timelines.Develop comprehensive regulatory documentation for submission to Health Authorities...


  • Københavns Kommune, Denmark Oresund Pharma ApS Full time

    We are looking for a new colleague to join our Regulatory department. Oresund Pharma is seeking a dedicated and experienced Regulatory Affairs Manager; in this role you will be responsible for Oresund Pharma's products worldwide with the purpose to develop and maintain a product portfolio following regulatory requirements and commercial demands. As a...


  • Glostrup Kommune, Denmark Agilent Technologies Full time

    Regulatory Affairs Specialist, IVDR Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do...


  • Gladsaxe, Gladsaxe Municipality, Denmark Kenvue Full time

    Job DetailsKenvue is seeking a highly experienced Senior Regulatory Affairs Specialist to join our team. The successful candidate will play a key role in ensuring that our products meet the highest regulatory standards.About YouWe are looking for a highly motivated and experienced regulatory affairs specialist with a strong background in regulatory...

Regulatory Affairs Lead

1 week ago


Gladsaxe Kommune, Denmark Novo Nordisk AS Full time

Category: Reg Affairs & Safety Pharmacovigilance

Location: Søborg, Capital Region of Denmark, DK

In Global Regulatory Affairs engaged people are committed to gaining regulatory approvals of Novo Nordisk’s medicines across the globe. Our people have a unique combination of scientific insight, patient focus, business understanding, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.
Apply now for a life-changing career

The position

As Regulatory Affairs Lead - late-stage development project in the RA CagriSema T2D & Amplify department, you will be part of a fantastic team of 13 people. You will work closely with GRL’s, Regulatory Leads and Regulatory Professionals within our department and across our portfolio.

Your main responsibilities include:

  1. Drive regulatory strategies and clinical regulatory activities for the assigned tracks within a large late-stage development project.
  2. Be a member of cross-functional project and submission teams, interacting with a variety of stakeholders from different departments in Novo Nordisk.
  3. As Regulatory Affairs Lead, be accountable for bringing regulatory strategic leadership and innovation to the project and proactively contribute to project team decisions.
  4. Lead the regulatory activities for the assigned tracks to ensure timely and high-quality regulatory deliverables to the global project teams.
  5. Work closely with other colleagues, ensure knowledge sharing within- and across projects, and provide sparring and mentoring to others.
  6. Report to the Senior Director of RA CagriSema T2D & Amplify and actively participate in department-related activities, including improvement projects across Global RA.

Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office and on-site work in Soeborg, Denmark where the department is based.

Qualifications

Your background covers a master’s degree within life sciences with 7+ years of relevant experience and/or PhD with 5+ years of relevant working experience, preferably within a pharmaceutical company.

To be successful in this role:

  1. You have solid regulatory experience including health authority interactions and an all-round understanding of regulatory requirements for drug development.
  2. You are driven by science and innovation, can understand complex scientific issues, and will be able to bring them into a regulatory context.
  3. You are well organized with solid project management skills and problem-solving capabilities.
  4. You have strong IT/digital skills and thrive with finding new ways to optimise our work.
  5. You are a good communicator and are comfortable using your fluent written and spoken English daily.

As a person, you thrive in a busy environment; bring a can-do spirit and a healthy sense of humour to your work – even when the pressure is on. You build effective working relations and are a flexible and change-oriented person who focuses on opportunities rather than limitations in challenging situations.

About the department

In RA CagriSema T2D & Amplify department, we contribute to the Novo Nordisk purpose of driving change to prevent chronic diseases by developing new treatment options for chronic conditions like type 2 diabetes and cardiovascular diseases. We are a team of 13 dedicated and highly engaged GRL’s, regulatory leads and professionals with diverse backgrounds and experiences.

Contact

For further information, please contact Senior Director Eva Lisby Arp-Hansen at +45 3079 0241.

Deadline

Please apply for the position no later than 2nd of February 2025.

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. Together, we’re life changing.

#J-18808-Ljbffr