Regulatory Affairs Specialist

1 week ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

About This Role

We are seeking an experienced Clinical Trial Submission Manager to join our CTA Management department. As a key member of our team, you will be responsible for leading the submission of initial Clinical Trial Applications (CTAs) and amendments to Health Authorities (HAs) and Ethics Committees (ECs). You will collaborate closely with stakeholders across Development and Affiliate to ensure timely and compliant submissions on a global scale.

  • Lead the CTA submission process and apply best practices to ensure timely submission.
  • Ensure CTA submission is in compliance with all applicable requirements worldwide.
  • Coordinate the preparation and monitoring of CTA documents for submission of initial CTAs and amendments.
  • Provide daily support to the team in analysis and problem-solving related to CTA submission activities.

What We Offer

You will be part of a dynamic and dedicated team responsible for running all clinical development activities from initial planning of clinical trials towards authority submission. Our CTA Management department is constantly evolving, and we work closely with our stakeholders to continuously improve our processes to adapt and ensure compliance with the increasingly complex regulatory environment. We offer interesting and challenging assignments and good opportunities for continuous personal and professional development.



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

    Job OverviewWe are seeking an experienced CMC Regulatory Specialist to join our team in Novo Nordisk A/S. As a key member of our regulatory affairs department, you will be responsible for providing strategic, tactical, and operational regulatory input to projects.The ideal candidate will have expertise in synthetic small molecules and experience working with...


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

    About the RoleWe are seeking an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic small molecules to join our team. As a key member of our regulatory affairs department, you will provide strategic, tactical, and operational regulatory input to projects. Your responsibilities will include...


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

    Select how often (in days) to receive an alert: Create Alert Regulatory Affairs Specialist, RA Obesity Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Are you passionate about regulatory science and driving innovative regulatory strategies to bring innovative medicines to patients? Do you have strong...


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

    About Novo Nordisk A/SWe are a dynamic company in an even more dynamic industry, always striving to drive change and move the needle on patient care.Our team is responsible for developing and executing global regulatory strategies, advancing projects across multiple indications from early development through worldwide submission and approval.As a Global...


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

    About the RoleWe are seeking an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist to join our Synthetics & Cell Technologies Department in the RA CMC Biotech & Rare Disease area within Novo Nordisk.The successful candidate will provide strategic, tactical, and operational regulatory input to projects, leading activities...


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

    About the Role:We are seeking a highly skilled Regulatory Affairs Business Development Director to join our team at Novo Nordisk A/S. As a member of our Regulatory Affairs Diabetes and Obesity team, you will play a pivotal role in creating global regulatory strategies to advance projects from the early stages of development to worldwide submissions and...


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

    At Novo Nordisk, we are committed to creating innovative solutions to improve the lives of patients worldwide.Company OverviewWe strive to be a leader in our industry by pushing boundaries, embracing new technologies, and fostering a culture of collaboration and innovation.The Regulatory Affairs Business Development team is responsible for evaluating...


  • Gladsaxe, Gladsaxe Municipality, Denmark Reckitt Benckiser Full time

    About the CompanyWe are Reckitt Benckiser, a global leader in hygiene, health, and nutrition. Our purpose is to protect, heal, and nurture in the pursuit of a cleaner, healthier world.The RoleAs a Regulatory Affairs Associate within our Hygiene division, you will be at the forefront of innovation and compliance efforts. You will work closely with a dynamic...


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

    Select how often (in days) to receive an alert: Create AlertExpert in Regulatory Affairs - Primary PackagingCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKAre you ready to take on new challenges in primary packaging development across emerging therapeutic areas and innovative products? Would you like to use...


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

    Key ResponsibilitiesAs a Regulatory Affairs Business Development Director at Novo Nordisk, you will be responsible for:Leading RA BD activities and establishing a Matrix Team covering all relevant regulatory skill areas.Evaluating external assets and companies for in-licensing, partnerships, or acquisitions across Novo Nordisk's therapeutic...


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

    About This RoleWe are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team within RA Obesity.In this role, you will be responsible for developing and executing late-stage regulatory strategies, collaborating with cross-functional teams, and overseeing regulatory submissions.Key responsibilities may include:Providing...


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

    Select how often (in days) to receive an alert: Create Alert Regulatory Affairs Business Development Director Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Do you have experience developing medicinal products and identifying regulatory risks and opportunities? Are you knowledgeable about the drug...


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

    Select how often (in days) to receive an alert: Create AlertRegulatory Affairs Business Development DirectorCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKDo you have experience developing medicinal products and identifying regulatory risks and opportunities? Are you knowledgeable about the drug development...


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

    About the DepartmentDigital Transformation is a department placed in RQ&C: RQ&C consists of the four functional areas: Regulatory Affairs (approvals by health authorities), R&D Quality (ensuring quality and compliance), Clinical Reporting (medical writing) and Digital Transformation (driving the Digital agenda). Furthermore, our department also supports the...


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

    Job Description:We are seeking a highly skilled Regulatory Affairs Business Development Director to join our team at Novo Nordisk A/S.The successful candidate will have a strong background in regulatory affairs and business development, with experience in evaluating external assets and companies for in-licensing, partnerships, or acquisitions. They will also...


  • 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

    We are seeking a highly skilled Professional to join our Regulatory Affairs (RA) Device and Digital Health department at Novo Nordisk A/S. The ideal candidate will have a strong background in regulatory affairs, with expertise in primary packaging development and submission planning.About the Role:This role offers a multi-disciplinary environment with...


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

    About the RoleNovo Nordisk A/S is seeking an experienced Regulatory Affairs Process Excellence Manager to join our RA Process and Digital Strategy area. As a key member of the team, you will play a central role in driving process excellence, innovation, and digital transformation across the regulatory affairs organization at a corporate level and across all...


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

    Company Overview:Novo Nordisk A/S is a leading healthcare company that focuses on developing innovative treatments for people with diabetes and other serious chronic conditions. Our vision is to make a significant difference in patients' lives by delivering high-quality products and services.We are committed to fostering a culture of innovation,...


  • 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...