Regulatory Manager, Global Affairs

We are looking for an exceptional Global Regulatory Affairs Manager to join our team. This individual will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects, representing RA in the Clinical Trial Teams, and ensuring progress of multiple clinical trial submission activities.The Role & DepartmentThis position...

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...

Are you passionate about developing life-changing treatments and making a meaningful impact on patients' lives? Do you have expertise in global regulatory affairs for biological products? If so, we invite you to join our team at Genmab A/S as a Regulatory Affairs Manager CMC.Responsibilities:Develop and execute sound and robust global regulatory CMC...

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...

Transform the lives of patients through innovative cancer treatment and other serious diseases with GenmabWe'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. Our people are caring, candid, and impact-driven, while our business...

At Genmab, we are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued...

Job DescriptionWe are looking for a skilled Director/Associate Director to join our Regulatory Affairs CMC team in Copenhagen, Denmark.You will be responsible for operational and strategic regulatory CMC input to support worldwide development and commercialization of biological products. Your main duties will include developing and executing sound global...

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...

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...

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,...

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...

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...

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...

Job DescriptionWe are seeking a highly skilled and experienced Strategic Director of Regulatory Affairs to join our team at Genmab. In this role, you will be responsible for developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.You will provide strategic input and...

About the JobHurecon, a leading pharmaceutical company, is seeking an experienced Regulatory Affairs professional to join our team in Copenhagen. As a key member of our regulatory department, you will be responsible for maintaining and following up on global Marketing Authorizations on the European Market.Key Responsibilities:Maintain and follow up on global...

Role OverviewWe are seeking a highly experienced Regulatory Affairs Leader EU/ROW to join our team at Genmab. In this role, you will be responsible for developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.You will provide strategic input and ensure operational...

At Radiometer Danmark / Danaher, we're pushing the boundaries of healthcare innovation. Our mission is to improve global healthcare with reliable, fast, and easy patient diagnoses. As a key member of our team, you'll play a vital role in driving process improvements and implementing systems and tools within Regulatory Affairs to support efficient regulatory...

Job SummaryWe 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...

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...

Black Swans Exist is revolutionizing women's health by developing innovative biologics, combination drug-device products, and companion diagnostics. We seek a visionary Director of Regulatory Affairs to lead our global regulatory strategies.About the RoleThis high-impact position drives the regulatory framework for clinical development, Phase 2, and beyond....