Director of Life Cycle Management for CMC

5 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Job Overview:

We are seeking a highly experienced and visionary leader to spearhead our team as the Director of Regulatory Affairs for CMC Biologics and Rare Diseases. This role requires a dynamic and ambitious individual with a strong track record of driving change and innovation in regulatory affairs.

Key Requirements:

  • A Master of Science degree in natural sciences such as engineering, pharmacy, chemistry or similar
  • 10+ years of experience as a leader and minimum 5 years as second line leadership required
  • 10+ years of experience from the pharmaceutical industry within Regulatory Affairs

About the Role:

This is an exciting opportunity to join a rapidly growing organisation dedicated to improving the lives of people living with serious chronic diseases. As the Director of Regulatory Affairs for CMC Biologics and Rare Diseases, you will play a pivotal role in shaping the future of RA CMC and driving excellence in our pipeline.

What We Offer:

Novo Nordisk offers a comprehensive range of benefits, including opportunities for professional growth and development, a collaborative and inclusive work environment, and a competitive compensation package.



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

    Director of Regulatory Affairs for CMC Biologics & Rare Diseases Category: Project Management & Agile Location: Søborg, Capital Region of Denmark, DK Are you an experienced purpose-driven and business-minded second line leader with extensive expertise in drug regulatory affairs? Do you excel in a dynamic environment and want to be part of a rapidly...


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

    Select how often (in days) to receive an alert: Create AlertCategory: Reg Affairs & Safety PharmacovigilanceLocation: Søborg, Capital Region of Denmark, DKWe are expanding our product and project pipeline in Novo Nordisk and are looking for an engaged Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic...


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

    As a key member of the Novo Nordisk PSQIT organisation, you will be part of Chemistry, Manufacturing and Control (CMC) Development & Scaling. Our team makes a real difference for patients with chronic diseases across the world by developing, manufacturing and distributing drug candidates for clinical trials.We are looking for an Automation Systems Specialist...


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

    Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Quality Ansøg nu Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials and thereby secure and support the development pipeline in Novo...


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

    Job Description:We are seeking an experienced leader to join our team as the Director of Regulatory Affairs for CMC Biologics and Rare Diseases. As a key member of our leadership team, you will play a pivotal role in shaping the future of RA CMC. Your expertise in drug regulatory affairs will drive excellence in our pipeline and deliver regulatory approvals...


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

    Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Digital & IT Do you want to be part of our ambitious journey to digitise and automate the processes in our API Pilot factories, where the insulin and GLP-1's of the future are being developed? Are you motivated to lead the design, implementation, and management of IT/OT solutions to enhance...


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

    Global Associate Director - Device Strategy & Marketing (12-month assignment)Category: Project Management & AgileLocation: Søborg, Capital Region of Denmark, DKOne of our Global Associate Directors is going on a 12-month short term assignment in another function, so now there is a unique opportunity for a 12-month assignment in Device Strategy &...


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

    Global Associate Director - Device Strategy & Marketing (12-month assignment) Category: Project Management & Agile Location: Søborg, Capital Region of Denmark, DK One of our Global Associate Directors is going on a 12-month short term assignment in another function, so now there is a unique opportunity for a 12-month assignment in Device Strategy &...


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

    Select how often (in days) to receive an alert: Create AlertAssociate Global Medical Director, MASH and Liver DiseasesCategory: Medical AffairsLocation: Søborg, Capital Region of Denmark, DKAre you a highly experienced medical professional with a keen interest in Liver and Cardiometabolic Diseases? Are you in search of an opportunity to apply your medical...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novozymes AS - Novonesis Full time

    As a Global Portfolio Manager, you will be responsible for overseeing the development and implementation of the Mental Health Category strategy and portfolio in Novonesis. This includes managing the Mental Health Global Portfolio life-cycle management process, identifying opportunities for growth, and collaborating with cross-functional teams to drive...


  • 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 Novo Nordisk AS Full time

    The Ideal CandidateWe are looking for an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic small molecules to join our team. The ideal candidate will have a Master's and/or Ph.D. degree in life sciences with regulatory CMC experience either from the pharmaceutical industry or from a health...


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

    Job Description:The Director of Regulatory Affairs for CMC Biologics will lead the development and execution of regulatory strategies for biologics and rare diseases. This role requires a seasoned leader with extensive experience in regulatory affairs, able to inspire and empower teams to deliver high-quality results.Key Responsibilities:Develop and execute...


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

    Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Quality Ansøg nu Would you like to play an important role in ensuring the quality and safety of products for clinical trials, where you can use your solid QA and validation experience in a project context? Then we can offer you a unique position with a lot of responsibility and impact in a dynamic...


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

    Jobbeskrivelse Placering Søborg, Denmark Jobkategori Clinical Development Ansøg nu Are you passionate about finding new solutions for rare Hemato-renal diseases? Do you possess extensive experience in clinical development and a deep understanding of how immunology impacts these conditions? If so, we are looking for an International Medical Director...


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

    Job DescriptionAs a Senior Clinical Project Lead, you will be responsible for end-to-end planning, execution, and completion of global trials. Your main responsibilities will include leading global cross-functional study teams, ensuring the trial team is well-functioning and effective, chairing of the trial squad, being overall accountable for the studies...


  • Gladsaxe, Gladsaxe Municipality, Denmark NNIT AS Full time

    We are seeking a skilled SAP Application Director to ensure the quality, performance, and reliability of multiple SAP applications for a leading life sciences customer.As a key member of our SAP Project Management and Application Management department, you will collaborate closely with the customer and NNIT's SAP specialists to maintain customer...


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

    JobbeskrivelsePlacering Søborg, DenmarkJobkategori Market Access Ansøg nu Are you ready to make a meaningful impact in the realm of rare disease treatment access? As the Global Director for Health Economics & Outcomes Research, you will be at the forefront of pioneering initiatives that shape the way rare disease treatments are perceived, valued, and...


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

    Jobbeskrivelse Placering Søborg, Denmark Jobkategori Market Access Ansøg nu Are you ready to make a meaningful impact in the realm of rare disease treatment access? As the Global Director for Health Economics & Outcomes Research, you will be at the forefront of pioneering initiatives that shape the way rare disease treatments are perceived, valued, and...


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

    Are you passionate about working with data? Do you want to set directions and deliver results? Do you have the ability to handle complex tasks? If yes, we are seeking an experienced and highly motivated Regulatory Data Partner to join our team, who will be responsible for implementing and supporting our data in the Regulatory organisation, and support...