Compliance and Regulatory Affairs Professional

About the RoleAt Genmab, we're pushing the boundaries of antibody therapies to transform lives. As a Director/Associate Director, Global Regulatory Affairs, you'll play a crucial role in shaping our regulatory strategy for biologics.This exciting opportunity requires a seasoned professional with expertise in CMC regulatory affairs, strategic thinking, and...

About the JobPandora A/S is seeking a highly motivated and experienced Regulatory Affairs Director to lead our global regulatory affairs function. As a key member of our team, you will be responsible for ensuring that we maintain the highest standards of regulatory compliance and integrity.Main ResponsibilitiesDevelop and implement effective regulatory...

Job SummaryThis role is an excellent opportunity for a seasoned Regulatory Affairs professional to lead regulatory projects both locally and globally. The ideal candidate will have a strong background in regulatory compliance, excellent communication skills, and the ability to work effectively in a fast-paced environment.The selected candidate will be...

We are looking for an exceptional individual to join our team as an Associate Director, Global Regulatory Affairs Project Lead. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring regulatory compliance and oversight for our clinical trials.In this role, you will represent RA in Clinical Trial Teams and...

We are looking for a Regulatory Compliance Lead to join our team at Macure Pharma. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines. Your expertise in eCTD publishing and regulatory submission workflows will be instrumental in shaping our digital regulatory...

Job Description Summary LOCATION: Copenhagen, DenmarkROLE TYPE: Hybrid working (3 days per week in the office) As a member of the Regulatory Affairs (RA) team in Copenhagen, you will get the opportunity to work in a dynamic, agile team who has a common goal to bring our medicines to patients. We are looking for a Regulatory Affairs Manager or...

Radiometer Danmark/Danaher is a leading company in diagnostics, partnering with customers across the globe to help them solve their most complex challenges. We're looking for a highly skilled Regulatory Affairs Professional to join our team and contribute to our mission.The successful candidate will possess an MSc in Engineering, Pharmacy, Biology,...

Black Swans Exist, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health, seeks a seasoned Director of Regulatory Affairs to spearhead their global regulatory strategies.About the RoleIn this high-impact position, you will drive the development and approval of innovative biologics, combination drug-device...

We are seeking a dedicated and experienced professional to join our Regulatory department as a Regulatory Affairs Manager. This role will be responsible for ensuring the compliance of Oresund Pharma's products with regulatory requirements worldwide.Key Responsibilities:Develop and maintain a product portfolio following regulatory requirements and commercial...

Get AI-powered advice on this job and more exclusive features. Senior Business Development Consultant at Black Swans Exist Director of Regulatory Affairs Are 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,...

At Radiobotics, we believe that quality assurance and regulatory compliance are essential to delivering high-quality medical devices. As a regulatory affairs expert, you will play a vital role in ensuring our products meet the highest standards of quality and safety.In this role, you will work closely with the development team to drive product release...

Oresund Pharma ApS is a Nordic-based privately owned specialty pharmaceutical company focusing on marketing value-added products in the European countries.We are seeking a dedicated and experienced Regulatory Affairs Manager to join our team. As a key member of our Regulatory department, you will be responsible for Oresund Pharma's products worldwide,...

About the RoleWe are seeking a highly experienced Senior Manager/Associate Director, EU/ROW Regulatory Lead to join our Global Regulatory Affairs organization. As an integral part of our team, you will be responsible for ensuring regulatory oversight and progress of clinical trial submissions in EU/ROW.In this role, you will represent RA in the Clinical...

This is an excellent opportunity for someone who is passionate about quality and regulatory affairs to join a leading company in the medical device industry. As a QA/RA specialist, you will be responsible for ensuring compliance with regulatory requirements, including MDR and ISO 13485, and will have the opportunity to work on a wide range of projects, from...

Job DescriptionThe Senior Regulatory Affairs Specialist is responsible for ensuring regulatory compliance and securing approvals for new products, line extensions, and additional claims. They will manage the coordination and submission of regulatory applications for drugs, cosmetics, medical devices, and similar products.This role requires strong knowledge...

About the Role:The Associate Director Regulatory Strategy will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects. This role will represent EU/ROW in the Global Regulatory Team(s) and work closely with CROs and internal stakeholders to ensure compliance with regulatory requirements.Key Responsibilities:Develop...

Job DescriptionWe are seeking an experienced and skilled professional to join our team as an Associate Director, Global Regulatory Affairs Project Lead. In this role, you will be responsible for managing the regulatory aspects of our clinical trials in EU/ROW, including preparing and submitting regulatory documents, leading EMA or national Scientific Advice...

At Genmab, we're committed to developing groundbreaking antibody products that transform the lives of patients suffering from cancer and other serious diseases. Our team is driven by a passion for innovation and a dedication to pushing the boundaries of what's possible.The Role & DepartmentWe're seeking an experienced Regulatory Affairs professional to join...

Radiometer Danmark/Danaher is proud to work at the forefront of diagnostic innovation. Our shared purpose unites over 4000 employees worldwide in a pursuit to improve patient care through technology and solutions.We are seeking an exceptional individual to join our Global Regulatory Affairs team as Senior Manager, RA Processes, Systems and Tools.As part of...

As Head of EU Regulatory Compliance, you will be responsible for ensuring that all regulatory requirements are met for our clinical trials in EU/ROW. This includes developing and implementing EU/ROW strategies, collaborating with CROs and internal stakeholders, and preparing and submitting regulatory documents.You will represent RA in Clinical Trial Teams...