Regulatory Affairs Specialist

We are seeking a dedicated and experienced Regulatory Affairs Manager.As part of our team, you will be responsible for Oresund Pharma's products worldwide with the purpose to develop and maintain a global product portfolio following regulatory requirements and commercial demands.As Regulatory Affairs Manager, you will be responsible for your own portfolio...

About the RoleWe are seeking an experienced leader to join our Global Regulatory Affairs organization as a Senior Director, Regulatory Affairs Strategy-EU/RoW. This role will be responsible for developing global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed products.The ideal candidate will have a strong...

Job OverviewGenmab A/S is seeking a highly motivated and experienced Regulatory Affairs professional to join our Global Regulatory Affairs team as an Associate Director, EU/ROW Regulatory Lead. The successful candidate will be responsible for representing RA in the Clinical Trial Teams, ensuring regulatory oversight and progress of multiple clinical trial...

We're Novo Nordisk A/S, a global leader in diabetes care and biopharmaceuticals. Our mission is to improve the lives of millions of people around the world. To achieve this, we need talented individuals who share our passion for innovation and excellence.We're looking for a skilled Regulatory Affairs Specialist - Chemicals to join our Nature and Chemicals...

At Genmab, we're committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.We're seeking a Senior Regulatory Affairs Manager to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible...

Sandoz International GmbH is a leading generic and biosimilar medicines company, committed to improving access to high-quality, low-cost medicines for patients worldwide. We are seeking a highly motivated Global Regulatory Affairs Manager to join our LCM Product team.In this role, you will be responsible for managing global regulatory affairs, including...

About the RoleThis is an exciting opportunity to join our team as a Regulatory Affairs Specialist for Site Activation in the Nordics region.You will be responsible for performing tasks at a country level associated with Site Activation (SA) activities, ensuring adherence to local and international regulations, standard operating procedures (SOPs), project...

Our Purpose Mastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart, and accessible. Our technology and innovation, partnerships...

We are looking for a new colleague to join our Regulatory department. Oresund Pharma is seeking a dedicated and experienced Regulatory Affairs Manager; in this role you will be responsible for Oresund Pharma's products worldwide with the purpose to develop and maintain a product portfolio following regulatory requirements and commercial demands. As a...

Radiometer Danmark / Danaher is a leading provider of diagnostic solutions. Our purpose is to improve global healthcare with reliable, fast, and easy patient diagnoses. As a key member of our team, you will be responsible for driving process improvements and implementing systems and tools within Regulatory Affairs to support efficient regulatory support for...

Oresund Pharma ApS is seeking a dedicated and experienced Regulatory Affairs Manager to join our team.Responsibilities:Lifecycle management of productsEnsuring compliance with regulationsPreparation and review of regulatory submissionsMaintenance of product informationMonitoring and setting timelinesKeeping up-to-date with legislation and...

We are seeking a dedicated and experienced Regulatory Affairs Manager to join our team at Oresund Pharma ApS.Job Description:The successful candidate will be responsible for developing and maintaining a global product portfolio following regulatory requirements and commercial demands. Key responsibilities include lifecycle management, ensuring products...

We are seeking an experienced Regulatory Affairs Professional to join our team. In this role, you will be responsible for ensuring compliance with regulatory requirements and commercial demands worldwide.As a key member of our Regulatory department, you will be the center of product maintenance activities, aware of your stakeholders, and understand the full...

We are seeking a Senior Regulatory Specialist to join our dynamic Regulatory Affairs CMC team at Genmab A/S.As a Senior Regulatory Specialist, you will be responsible for providing operational and strategic regulatory CMC input to support worldwide development and commercialization.You will work closely with cross-functional teams to ensure compliance with...

Radiobotics is a dynamic and innovative company dedicated to solving the global need for radiologists while ensuring every patient receives expert-level care. We are looking for a talented QA/RA specialist to join our Clinical and Regulatory team and contribute to our mission.The ideal candidate will have a strong background in quality assurance and...

The Director of Regulatory Affairs ensures that the company's products meet global regulatory requirements, focusing on the USA and Europe, including those set by the FDA, EMA, and other relevant authorities. This role is responsible for developing and executing regulatory compliance strategies, navigating approval processes for pharmaceuticals and medical...

At Genmab, we are committed to pushing the boundaries of cancer treatment through innovative therapies. As a key member of our Global Regulatory Affairs organization, you will play a vital role in developing and executing EU/ROW regulatory strategies for our compounds.">The Role & DepartmentYou will join our dynamic team as an (Associate) Director, Global...

About This OpportunityWe're looking for an experienced Senior Regulatory Affairs Professional to join our team at Genmab. As a key member of our Global Regulatory Affairs organization, you'll play a critical role in developing and executing the EU/ROW regulatory strategy for assigned projects. Your expertise will be essential in ensuring regulatory...

About GenmabAt Genmab, we're a biotechnology company with a mission to transform the lives of patients through innovative cancer treatment and therapies. We're driven by our core purpose to strive towards improving patient outcomes with next-generation antibody technology platforms and translational research. Our team is passionate about developing...

We are looking for a new regulatory colleague for our life cycle management (LCM) Product team at Sandoz Nordic. Here, you will be responsible for our marketing authorisations for affiliate life cycle activities, of a defined portfolio.Here, you are given the opportunity to deep dive into the products and be the best sparring partner possible for your...