Regulatory Affairs Manager

We are seeking a highly experienced Regulatory Publisher & Submission Manager to join our Regulatory Affairs Team in Copenhagen or Malta.As a key member of our team, you will be responsible for:Regulatory publishing: compiling, formatting, and validating regulatory submissions in eCTD.System implementation: playing a key role in the implementation of our new...

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...

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 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...

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...

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...

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,...

**Job Summary**GROHE AG seeks a Regulatory Affairs Manager to lead the development and implementation of trade compliance strategies across the organization. The ideal candidate will have a strong background in trade regulations and laws, as well as excellent leadership and communication skills.**Key Responsibilities**Develop and maintain comprehensive...

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...

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...

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...

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,...

Transform Lives through Innovative Cancer TreatmentWe are 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. From our people who are caring, candid, and impact-driven to our business, which is innovative and...

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...

We are seeking a skilled and experienced Regulatory Affairs Director to join our team at Genmab A/S. As a key member of our Regulatory Affairs CMC team, you will be responsible for providing strategic regulatory guidance and support for the development and commercialization of our biologic products.The ideal candidate will have a strong understanding of...

Job Summary:We are seeking a highly skilled Quality and Regulatory Affairs Consultant to join our Clinical and Regulatory team. The ideal candidate will have a strong background in quality assurance and regulatory affairs, with experience in medical devices. You will be responsible for ensuring that our medical devices meet the highest quality standards and...

At Macure Pharma, we are seeking a seasoned Regulatory Affairs Specialist to join our team. This role offers an exciting opportunity to shape regulatory processes in a fast-growing company and play a key role in the implementation of our new Submission Publishing Tool.Key Responsibilities:Compiling, formatting and validating regulatory submissions in eCTD...

About the TeamOur Global Regulatory Affairs team is responsible for ensuring that Genmab's programs meet regulatory requirements and are developed and implemented in accordance with EU and international regulations. We work closely with cross-functional teams to ensure that our programs are developed and implemented in a way that meets regulatory...

Job Description:We are looking for a Regulatory Affairs Expert for Medical Devices to join our Clinical and Regulatory team. The ideal candidate will have a strong background in regulatory affairs, with experience in medical devices. You will be responsible for ensuring that our medical devices meet the highest regulatory standards and that we comply with...