Global Product Approvals Manager

7 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Kenvue Full time

We are looking for a highly motivated and experienced Regulatory Affairs professional to join our team as a Senior Regulatory Affairs Specialist. In this role, you will be responsible for ensuring regulatory compliance and securing approvals for new products, line extensions, and additional claims, while supporting business objectives.

The ideal candidate will have relevant Bachelor's Degree or higher, 6+ years related regulatory experience, and expertise across a broad spectrum of Regulatory classifications. They will possess solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance and fluent proficiency in Danish & English.

Key responsibilities include:

  1. Providing regulatory input and technical guidance on local regulatory requirements
  2. Assessing the acceptability of quality, preclinical, and clinical documentation for submission filing
  3. Preparing and submitting regulatory submissions according to applicable regulatory requirements and guidelines

You will also maintain awareness of current regulations, anticipate implications and opportunities, and communicate changes to appropriate management and cross-functional experts.



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

    Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Legal, Compliance & Audit Ansøg nu Are you eager to contribute to Novo Nordisk Product protection program and to ensure patient safety against counterfeit medicines? Do you aspire a career within Global Security and are you passionate about security investigations and cross functional projects with...


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

    Job OverviewWe are seeking a highly skilled Global Product Security Manager to join our Global Security team at Novo Nordisk. As a key member of our team, you will be responsible for designing and implementing product investigation processes, guidelines, and methodologies to protect our products and ensure patient safety.Your key responsibilities will...


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

    About the RoleAs a Global Product Security Manager at Novo Nordisk, you will play a crucial role in protecting our products and ensuring patient safety against counterfeit medicines. Your responsibility will be to design and implement product investigation processes, guidelines, and methodologies to combat counterfeiting, theft, and fraud.You will be...


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

    Job DetailsThe job involves working with Contract Manufacturing Organizations (CMOs) located around the world to ensure QA oversight by activities such as visits at the CMO, compliance checks, approval of QMS documents, and release of Novo Nordisk insulin products to the market.You will be part of a highly skilled QA team that delivers best-in-class Quality...


  • Gladsaxe, Gladsaxe Municipality, Denmark Kenvue Full time

    Kenvue is committed to delivering high-quality products that meet the needs of consumers worldwide. As a Global Product Approvals Manager, you will be responsible for securing approvals for new products, line extensions, and additional claims, while supporting business objectives.The ideal candidate will have expertise across a broad spectrum of Regulatory...


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

    About the RoleWe are seeking a skilled Launch Project Manager to join our Product Supply Launch Office. As a key member of our team, you will be responsible for ensuring timely product availability for launches assigned to you.Key Responsibilities:Develop and implement launch roll-out plans to secure timely product availabilityCollaborate with...


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

    Join us as a Principal Digital Process Lead, where you will leverage your expertise in GCP and regulatory requirements to drive digital transformation across our clinical process management team.Your key responsibilities will include:Digitalisation of key processes and proceduresVerifying and approving Standard Operating Procedures (SOPs) and ensuring...


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

    Job Summary:The Director of Regulatory Affairs for CMC Biologics will be responsible for developing and executing regulatory strategies for biologics and rare diseases. This role requires a highly experienced and visionary leader who can inspire and empower teams to deliver high-quality results.Key Challenges:Developing and executing global approval...


  • Gladsaxe, Gladsaxe Municipality, Denmark Scandinavian Tobacco Group AS Full time

    JOB TITLE - Global Rewards Manager LOCATION - Copenhagen (HQ) HOURS – Full time ABOUT THE ROLE: We have an exciting opportunity for a Global Rewards Manager to join our team. As the Global Rewards Manager, you will play a crucial role in executing our rewards strategies and supporting the different Executive Board areas. This hands-on role requires...


  • Gladsaxe, Gladsaxe Municipality, Denmark AgainBio (Luabio Aps, Secondcircle Aps) Full time

    About AgainBio We are a pioneering company that is revolutionizing the way we approach carbon emissions. Our mission is to turn CO2 into valuable, emission-free green chemicals. We believe that by fermenting CO2, we can make it the solution to this global problem.Our team has developed a novel fermentation-based bio-manufacturing technology that enables us...


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

    Select how often (in days) to receive an alert: Create Alert Advanced QA for External Production at CMO Category: Quality Location: Søborg, Capital Region of Denmark, DK Do you want to work in one of the most interesting and challenging areas in Novo Nordisk? Are you passionate about Quality Assurance and Quality Management Systems (QMS)? Are you eager to...


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

    About the RoleNovo Nordisk A/S is seeking a highly skilled and experienced Senior Clinical Project Lead to join our dynamic global clinical development team in the Cardiovascular, Kidney and Alzheimer Disease (CKAD) area. As a Senior Clinical Project Lead, you will be responsible for leading cross-functional study teams, driving clinical trials successfully,...


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

    Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Project Management & Agile Ansøg nu Are you motivated by making a difference and being part of a team of ambitious talents with diverse backgrounds? Would you like to drive complex improvement projects across our manufacturing sites globally? Do you have an Operational Excellence background? If so,...


  • Gladsaxe, Gladsaxe Municipality, Denmark Scandinavian Tobacco Group AS Full time

    Job DescriptionWe have an exciting opportunity for a Global Marketing Leader to join our team at Scandinavian Tobacco Group A/S.The successful candidate will be responsible for driving new product launches to support brand growth, supporting brand communication toolkit development, product concepts, and packaging redesign.ResponsibilitiesDrive new product...


  • Gladsaxe, Gladsaxe Municipality, Denmark Terma AS Full time

    About Terma A/STerma A/S is a leading provider of advanced defense and aerospace solutions. We are committed to delivering cutting-edge technologies that secure people on land, at sea, and in the air.Role OverviewWe are seeking a highly qualified Digitalization Expert to join our Product Management team. As a key member of this team, you will be responsible...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. The QA Manufacturing Support Scientist is responsible for quality...


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

    About Novo Nordisk:Novo Nordisk A/S is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Our success relies on the joint potential and collaboration of our more than 69,000 employees around the world. We recognize the importance of unique skills and perspectives our people bring to the table.Key...


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

    About the JobThis role offers the opportunity to work with Contract Manufacturing Organizations (CMOs) located around the world. You will be responsible for ensuring QA oversight by activities such as visits at the CMO, compliance checks, approval of QMS documents, and release of Novo Nordisk insulin products to the market.You will work with a highly skilled...


  • Gladsaxe, Gladsaxe Municipality, Denmark Kenvue Full time

    Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation. Job Description - Senior Regulatory Affairs Specialist (2507030367W) Who we are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands —...


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

    Job OverviewWe are seeking an experienced Global Pharmaceutical Leader to join our team as Corporate Vice President, CETA Early Portfolio. This role will be responsible for overseeing a rapidly growing pipeline portfolio of commercial projects, significantly contributing to Novo Nordisk's long-term growth.The ideal candidate will have a strong understanding...