Regulatory Affairs Specialist

About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to develop and execute the late-stage regulatory strategy for a key project. This role requires strong scientific knowledge and regulatory expertise to evaluate strategies, manage multiple regulatory tasks with overlapping timelines, and collaborate closely with Global Regulatory...

OverviewJob Title: Regulatory Affairs Specialist for Rare Disease DevelopmentThe Novo Nordisk A/S RA Rare Bleeding Disorders department is part of the company's Global Regulatory Affairs and situated in Søborg, Denmark. Our team contributes to the development of different products and projects within Rare Bleeding Disorders with a pipeline including various...

Job Description\Novo Nordisk A/S is seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs and be able to drive the strategic direction of innovative development projects.\Main Responsibilities:\\Execute and drive the regulatory strategy to obtain approvals\Provide...

At Novo Nordisk, we are expanding our product and project pipeline and 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. This role provides strategic, tactical, and operational regulatory input to projects.The...

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 Novo NordiskWe're a dynamic company in the biopharmaceutical industry, dedicated to driving innovation and making a meaningful impact on patient care.Our commitment to excellence is evident in our research and development efforts, where we strive to move the needle on therapeutic areas like obesity.The RoleWe're seeking a skilled Regulatory Affairs...

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...

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...

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...

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...

Select how often (in days) to receive an alert: Create Alert (Senior) Regulatory Affairs Professional, RA Obesity - Maternity cover Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Do you have a talent for navigating complex regulatory landscapes and driving strategic initiatives? Are you eager to contribute...

About the RoleWe are seeking a highly skilled Global Regulatory Lead to join our team at Novo Nordisk A/S. As a key member of our Regulatory Affairs department, you will play a crucial role in developing and executing regulatory strategies for early to mid-stage development projects within the Cardiovascular and Chronic Kidney Diseases therapeutic area.The...

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...

About UsWe are committed to securing process excellence and digital innovation to reach more patients faster by simplifying and standardizing ways of working with a focus on end users. Our Regulatory Affairs team manages submission, registration, and labelling to obtain authority approval for all Novo Nordisk products. We work across the value chain from...

Key ResponsibilitiesContribute regulatory expertise to global strategies and tacticsDevelop regulatory documentation for submission to Health Authorities globally, e.g., clinical trial applications, briefing packages, paediatric plans, and responses to health authority questionsRepresent Global Regulatory Affairs in global clinical trial teams and other...

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...

Navigating Complex Regulations to Drive Business SuccessIn this dynamic role, you will leverage your expertise in regulatory affairs to drive business growth and expansion while ensuring compliance with product safety standards and regulatory requirements in Nordic markets. As a Regulatory Affairs Associate in our Hygiene division, you will develop and...

We are recruiting for a Regulatory Affairs and Clinical Trials professional to join our team at Novo Nordisk A/S. As a Global Trial Manager, you will play a critical role in ensuring the quality and integrity of our clinical trials.Key responsibilities include:Ensuring compliance with regulatory requirements, good clinical practices, and internal...

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...

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...