Biopharmaceuticals Regulatory Affairs Specialist

Regulatory Affairs Specialist (MedTech) – 6 Month Contract | CopenhagenOn behalf of an exciting client in the medical device industry, we are looking for a Regulatory Affairs Specialist for a 6-month freelance assignment based in Copenhagen.You will support regulatory activities for innovative medical devices, ensuring compliance with MDR and other...

The role of a Regulatory Affairs Specialist at Hurecon involves managing the entire lifecycle of European Union (EU) procedures from application submission to national implementation. This position requires a strong understanding of regulatory legislation and guidelines in the pharmaceutical industry.Responsibilities:Maintain and follow up on global...

We are seeking a Regulatory Affairs Specialist to join our Life Cycle Management (LCM) Product team at Sandoz Nordic.This role involves responsible for all life cycle management activities for your defined portfolio, ensuring regulatory compliance and collaborating with Supply Chain/Planning/QA/QC and Global RA teams.The ideal candidate will have a strong...

About the Role\As a Senior Counsel, Regulatory Affairs, you will be part of Mastercard's Global Regulatory Team, responsible for facilitating the strategic development of our open banking business in Europe. This role is based in Denmark and will support Mastercard Open Banking Services EU (MCOBS EU) subsidiary that holds PIS and AIS regulatory license in...

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...

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...

We are seeking a dedicated and experienced professional to join our Regulatory department as a Regulatory Affairs Manager. This role will be responsible for maintaining and developing a product portfolio following regulatory requirements and commercial demands.Key ResponsibilitiesEnsure timely delivery of regulatory plans in alignment with business...

Join Our TeamWe are seeking an experienced Regulatory Affairs professional to join our Global Regulatory Affairs organization as a Director, Global Regulatory Affairs Project Lead. The successful candidate will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects and ensuring regulatory oversight of clinical trial...

Genmab A/S is dedicated to creating life-changing antibody therapeutics for patients with cancer and other serious diseases. As a Regulatora Affairs Strategist in our Global Regulatory Affairs organization, you will play a key role in shaping the regulatory strategy for our products.Your primary responsibility will be to support the Global Regulatory Lead...

We are Radiobotics, a company driven by aspiration, curiosity, and playfulness. We believe in integrity, transparency, and open communication. Our vision is to augment routine X-rays of the musculoskeletal system, enabling non-specialists to read radiology images assisted by our products, and ensuring patients have access to immediate expert-level evaluation...

Innovative solutions for a better tomorrowRadiometer Danmark / Danaher is committed to improving global healthcare with reliable, fast, and easy patient diagnoses. We strive to make a difference in people's lives by providing cutting-edge technology and solutions.The Senior Manager, RA Processes, Systems and Tools plays a crucial role in driving process...

Job Title: Regulatory Affairs CoordinatorIQVIA Argentina is seeking a highly skilled Regulatory Affairs Coordinator to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements, providing training and support to sites, and collaborating with the study team to track the progress of assigned studies.Key...

Get AI-powered advice on this job and more exclusive features.Senior Business Development Consultant at Black Swans ExistDirector of Regulatory AffairsAre you ready to take on a pivotal role in shaping the future of women's health? Our client, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health, seeks a...

About the PositionWe are seeking a highly skilled Regulatory Affairs professional to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will have the opportunity to utilize your expertise to drive regulatory compliance and quality in clinical trials.ResponsibilitiesDrive regulatory compliance and quality in...

Job Overview:This is a mid-senior level full-time position requiring a strong understanding of CMC development and regulatory affairs.Coordinate inputs across departments and external stakeholdersManage risk proactively using scientific and operational insightPrepare and facilitate technical project meetingsKey Skills:Project management experience in biotech...

The Regulatory Affairs Consultant will play a crucial role in ensuring that our organization adheres to national and international legislation and guidelines regarding compliance and audits.Key DeliverablesDevelop policies and procedures for compliance and risk managementConduct regular training sessions for employees on compliance and risk...

Company OverviewRadiometer Danmark / Danaher is a leading company in the diagnostics industry, working towards improving global healthcare with reliable, fast, and easy patient diagnoses. We are proud to work alongside a community of six fellow Diagnostics Companies at Danaher.Job DescriptionThe Senior Manager, RA Processes, Systems and Tools for Radiometer...

About the RoleWe are seeking a highly skilled Biopharmaceutical Integration Specialist to join our CMC Integration Team in New Product Introduction (NPI) CMC. The NPI team is responsible for Early-Stage CMC development covering preclinical to early/mid clinical stage CMC work.The ideal candidate will have a strong background in bioprocess technology and...

Why Join UsGenmab offers a unique opportunity to work with a talented team of professionals who share a passion for innovation and excellence. As a member of our Regulatory Affairs CMC team, you will have the chance to develop and execute global regulatory CMC strategies, collaborate with cross-functional teams, and prepare CMC documentation for various...

Oresund Pharma ApS is a Nordic based privately owned specialty pharmaceutical company focusing on marketing value-added products in the European countries. We work with a large network of contract manufacturers, suppliers, wholesalers, and distributors, which provide us with a very dynamic, flexible, and scalable business structure.Our team consists of 4...