Regulatory Professional in CMC

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...

We're committed to creating an inclusive culture that celebrates diversity and promotes equality of opportunity for all job applicants. At Novo Nordisk, we recognize that being the best company in the world is no longer good enough; we need to aspire to be the best company for the world.About the RoleAs a CMC Regulatory Specialist, you'll contribute to...

Key ResponsibilitiesAs a Regulatory Affairs Professional, you will be responsible for:Planning, coordinating and executing regulatory submissions.Creating, planning and coordinating submission timelines in collaboration with CMC subject matter experts (SME), affiliates and other key stakeholders.Defining and driving needed updates of the Quality (M3) drug...

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...

CMC Regulatory Strategy LeadAbout Our CompanyNovo Nordisk A/S is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient...

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...

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,...

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...

Novo Nordisk is driving change in the industry by embracing experimentation and striving for excellence without fixating on perfection. We're a dynamic company in a fast-paced environment, working together to move the needle on patient care.Job DescriptionThis is an opportunity to work on synthetic small molecules, including process design, analytical...

We are seeking an experienced purpose-driven and business-minded second line leader with extensive expertise in drug regulatory affairs to join our team as the Director of Regulatory Affairs for Biologics and Rare Diseases.About the roleAs the Director for RA CMC Biologics & Rare Diseases, you will play a pivotal role in shaping the future of RA CMC. We are...

Our RA CMC & Device organization is looking for a Regulatory Affairs Professional to handle RA CMC activities for our marketed Oral Products at Novo Nordisk A/S. This role offers a unique opportunity to make a meaningful impact on the regulatory compliance of our products in all global markets.The ideal candidate will have a Master's degree or PhD in a...

We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.We embrace the spirit of experimentation, striving for excellence without fixating on perfection.We never shy away from opportunities to develop, we seize them.From research 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...

Job DescriptionWe are seeking a highly skilled Regulatory Affairs Professional to join our RA CMC & Device team. As a key member of our organization, you will play a crucial role in ensuring the success of Novo Nordisk's expanding product portfolio.About the RolePlan, coordinate and execute regulatory submissions.Create, plan and coordinate submission...

Regulatory Affairs Leader for Biologics and Rare DiseasesAbout Our TeamThe newly established RA CMC BRD Development Projects & LCM is one of three areas in RA CMC Biologics & Rare Diseases, which is a VP area organized in the RA CMC & Device organization with 270 employees.Our VisionAs Director, you will lead and develop leaders and specialists organized in...

Company Overview">At Novo Nordisk A/S, we strive to be a leader in diabetes care and innovative biopharmaceuticals. Our company has been committed to improving the lives of people with diabetes for more than 90 years.We are dedicated to developing innovative medicines that make a meaningful difference to patients' lives, from early discovery to late-stage...

Global Regulatory CMC Leadership RoleAbout Our CultureWe 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.About the JobWe are seeking a highly...

About the RoleWe are looking for a skilled and experienced Regulatory Compliance Expert to join our CMC API QA team.In this role, you will be responsible for ensuring compliance with regulatory requirements, quality standards, and company policies in the manufacturing of APIs.You will also participate in regulatory inspections and audits, and ensure that our...

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...