Regulatory CMC Lead

At Novo Nordisk A/S, we are expanding our product and project pipeline in a fast-paced, dynamic environment.We are 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 ideal...

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...

Director of Regulatory Affairs for CMC Biologics & Rare DiseasesCategory: Project Management & AgileLocation: Søborg, Capital Region of Denmark, DKAre 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 growing...

Job ResponsibilitiesThe successful candidate will be responsible for providing strategic, tactical, and operational regulatory input to projects in late development. This includes leading activities for synthetic small molecule projects, driving scientific and regulatory discussions, and working closely with stakeholders across multiple functions.Key...

Job DescriptionAs a Regulatory Affairs Professional, you will play a key role in ensuring fast and successful regulatory submissions and approvals in all global markets. You will join an experienced team working with oral products, focusing on RA CMC life-cycle management activities.Your main responsibilities will include:Planning, coordinating, and...

At Novo Nordisk A/S, we are seeking a highly skilled Regulatory Affairs Professional to join our team. This role will play a key connection between scientists and Health Authority regulators, ensuring fast and successful regulatory submissions and approvals in all global markets.About the RoleThis is an exciting opportunity for a talented individual to join...

About the RoleThis position is ideal for a motivated and experienced regulatory affairs professional looking to make a difference in patient care. As a CMC Regulatory Specialist, you will be part of a dynamic team driving regulatory affairs strategies and submission activities related to emerging technologies and synthetic small molecules.You will work...

Job DescriptionWe are seeking a highly skilled CMC Regulatory Specialist to join our RA CMC Synthetics & Cell Technologies department in Novo Nordisk A/S. As a key member of the team, you will provide strategic, tactical, and operational regulatory input to projects in late development.Your primary responsibility will be to lead activities for synthetic...

We are seeking an exceptional leader to join our CMC API Process Operations team as a Manager for CMC Shipping, Quality & Training. As a member of our team, you will play a critical role in leading a team of 15 employees responsible for ensuring the success and integrity of our API processes.Responsibilities:Manage the shipment process, including...

Select how often (in days) to receive an alert: Create AlertCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKDo you want to be part of a growing organization, contributing to the success of Novo Nordisk's expanding product portfolio? Are you passionate about regulatory guidelines and committed to ensuring...

Job Overview:Novo Nordisk A/S is seeking a skilled and experienced Regulatory Affairs Business Development Director to lead RA BD activities and collaborate with the BD Director and regulatory specialists to evaluate external assets and companies for in-licensing, partnerships, or acquisitions across NN's therapeutic areas.The successful candidate will be...

Novo Nordisk A/S is seeking a highly skilled Regulatory Affairs Professional to join our team. In this role, you will play a key role in ensuring the success of our regulatory submissions and approvals. You will work closely with scientists and Health Authority regulators to ensure the smooth execution of regulatory activities, focusing on the creation,...

Senior QP delegates play a crucial role in ensuring the quality and safety of products used in clinical trials at Novo Nordisk A/S. We are seeking an experienced professional to join our CMC API QA team and take on this important responsibility.The role involves releasing internal and externally produced API for usage in the Novo Nordisk clinical trial...

Select how often (in days) to receive an alert: Create Alert Manager for CMC Shipping, Quality & Training Category: Manufacturing Location: Søborg, Capital Region of Denmark, DK Ready to join a business area that ensures the success and integrity of Active Pharmaceutical Ingredients (API) processes in Novo Nordisk development projects? Curious about working...

Job Description">In this role, you will be responsible for evaluating external assets and companies for in-licensing, partnerships, or acquisitions across Novo Nordisk's therapeutic areas. You will also serve as a strategic business partner within global Regulatory Affairs in relation to Novo Nordisk's existing portfolio and lead portfolio-wide...

About the Role">This position offers the chance to work on exciting projects and contribute to Business Development (BD) activities across Novo Nordisk's therapeutic areas, representing Global Regulatory Affairs within the Global Project BD Team.">You will be responsible for leading Regulatory BD activities and establishing a Matrix Team covering all...

JobbeskrivelsePlaceringBagsværd, DenmarkJobkategoriQualityAnsøg nuDo 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 Nordisk?...

About the Department">The Regulatory Affairs Diabetes and Obesity therapeutic area is responsible for creating global regulatory strategies to advance projects from the early stages of development to worldwide submissions and approvals of initial Marketing Authorisation applications.">As a key member of this team, you will collaborate with cross-functional...

About Novo Nordisk A/SNovo Nordisk A/S is a leading healthcare company with a strong commitment to innovation and quality. Our CMC API QA team is responsible for assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials, and the release of API for clinical trials.Your Career PathYou will have the opportunity...

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...