Strategic Regulatory Affairs Leader

Join Black Swans Exist, a pioneer in microbiome-based therapies for women's reproductive health, as a Director of Regulatory Affairs. This pivotal role demands a visionary leader who can drive global regulatory strategies and navigate complex regulatory landscapes.About the PositionIn this high-stakes position, you will oversee the development and approval...

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,...

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...

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...

Genmab is a pioneering biotechnology company with a core purpose to transform the lives of patients through innovative antibody therapeutics.We're looking for an experienced and passionate leader to be part of our Global Regulatory Affairs organization. In this role, you will develop global strategies to advance Genmab's portfolio of development pipeline...

About the JobWe are seeking a seasoned Regulatory Affairs professional to join our Global Regulatory Affairs team. As a Senior Director, you will be responsible for the development and implementation of EU/ROW regulatory strategies for Genmab's programs across all stages of development. You will work closely with cross-functional teams to ensure an optimal...

We're a fast-growing biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics.We're looking for an experienced and passionate leader to be part of our Global Regulatory Affairs organization. In this role, you will develop global strategies to advance Genmab's portfolio of development pipeline candidate drugs...

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...

General Role Overview: The Global VP/Head of Public Policy and Regulatory Affairs will lead AstroPay's global regulatory strategy, ensuring compliance, alignment and influence in a rapidly evolving fintech environment with a strong international focus. This executive role will oversee the company's engagement with regulatory bodies, shape public policy...

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 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...

Job Overview:The Senior Director of Global Regulatory Affairs will lead Tbwa Chiat/Day Inc's global regulatory strategy, ensuring compliance with international financial regulations and alignment with business objectives. This role involves overseeing the company's engagement with regulatory bodies, shaping public policy initiatives, and ensuring seamless...

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...

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 RoleWe are seeking an experienced Global Regulatory Affairs Project Lead to join our team in Copenhagen, Denmark. In this role, you will be responsible for leading the development and execution of the EU/ROW regulatory strategy for assigned projects.Key ResponsibilitiesAct as EU/ROW regulatory lead and EMA contact person for assigned...

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...

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...

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...

About RadiometerRadiometer is a leading manufacturer of in vitro diagnostic instruments and consumables, dedicated to improving global healthcare through reliable, fast, and easy patient diagnoses. Our vision is to improve patient lives by making accurate diagnoses possible.As a key member of our team, you will be responsible for driving process improvements...