Regulatory Affairs Specialist
3 days ago
We are looking for a skilled Medical Writer Consultant to join our team at Pharma IT. In this role, you will work on-site or remotely with our clients in the pharma, biotech, and medical device industries.
Key Responsibilities:
- Write and review nonclinical documents for regulatory submissions.
- Work closely with cross-functional teams to deliver high-quality results.
- Ensure compliance with regulatory requirements and industry standards.
Qualifications:
- 5+ years of experience with medical writing.
- Strong understanding of clinical development and ICH guidelines.
- Excellent written and verbal communication skills.
-
Regulatory Affairs Specialist
5 days ago
Copenhagen, Copenhagen, Denmark Lunar Denmark Full time**Company Overview**Lunar is a dynamic and innovative company that operates at the intersection of technology and finance. We are passionate about empowering people to manage their finances effectively and securely.As a Compliance Specialist, you will play a critical role in shaping our company's approach to regulatory compliance. You will work closely with...
-
Regulatory Affairs Specialist
4 days ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeThe Director of Regulatory Affairs at Black Swans Exist is responsible for ensuring that the company's products meet global regulatory requirements, focusing on the USA and Europe. This role develops and executes regulatory compliance strategies, navigates approval processes for pharmaceuticals and medical devices, and ensures timely updates for existing...
-
Regulatory Affairs Director
7 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab, we're committed to creating extraordinary futures together by developing innovative antibody products and therapies that change the lives of patients. As our Senior Manager EU/ROW Regulatory Affairs, you'll play a crucial role in shaping our regulatory strategy and ensuring compliance with EU and ROW regulations.As a key member of our Global...
-
Regulatory Affairs Leader
3 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob OverviewGenmab A/S is seeking a highly motivated and experienced Regulatory Affairs professional to join our Global Regulatory Affairs team as an Associate Director, EU/ROW Regulatory Lead. The successful candidate will be responsible for representing RA in the Clinical Trial Teams, ensuring regulatory oversight and progress of multiple clinical trial...
-
CMC and Global Regulatory Affairs Specialist
7 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the JobGenmab A/S is seeking an experienced Director/Associate Director, Global Regulatory Affairs to join our Regulatory Affairs team. The successful candidate will provide strategic regulatory guidance on CMC topics, collaborate with cross-functional peers, and plan and prepare CMC documentation for clinical applications, marketing authorization...
-
Regulatory Affairs Specialist
6 hours ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeWe're Novo Nordisk A/S, a global leader in diabetes care and biopharmaceuticals. Our mission is to improve the lives of millions of people around the world. To achieve this, we need talented individuals who share our passion for innovation and excellence.We're looking for a skilled Regulatory Affairs Specialist - Chemicals to join our Nature and Chemicals...
-
Senior Regulatory Affairs Manager
3 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab, we'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 and serious diseases.We're seeking a Senior Regulatory Affairs Manager to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible...
-
Global Regulatory Affairs Lead
7 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob DescriptionThe Regulatory Affairs team at Genmab A/S is seeking an experienced professional to fill the role of Director/Associate Director, Global Regulatory Affairs. The successful candidate will be responsible for providing strategic regulatory guidance on CMC topics, collaborating with cross-functional peers, and planning and preparing CMC...
-
Regulatory Affairs Manager
7 days ago
Copenhagen, Copenhagen, Denmark European Federation Of Organizations For Medical Physics - EFOMP Full timeWelcome to Euro Federation of Organizations for Medical Physics - EFOMP, where we strive to bring innovative medical solutions to the market while prioritizing patient safety and well-being. As a Regulatory Affairs Manager, you will be a crucial member of our team, responsible for ensuring our products comply with relevant regulations and standards.You will...
-
Copenhagen, Copenhagen, Denmark IQVIA LLC Full timeAbout the RoleThis is an exciting opportunity to join our team as a Regulatory Affairs Specialist for Site Activation in the Nordics region.You will be responsible for performing tasks at a country level associated with Site Activation (SA) activities, ensuring adherence to local and international regulations, standard operating procedures (SOPs), project...
-
Senior Counsel, Regulatory Affairs
5 days ago
Copenhagen, Copenhagen, Denmark CareerArc Full timeOur Purpose Mastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart, and accessible. Our technology and innovation, partnerships...
-
Regulatory Affairs Systems Manager
2 days ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeRadiometer Danmark / Danaher is a leading provider of diagnostic solutions. Our purpose is to improve global healthcare with reliable, fast, and easy patient diagnoses. As a key member of our team, you will be responsible for driving process improvements and implementing systems and tools within Regulatory Affairs to support efficient regulatory support for...
-
Senior Manager EU Regulatory Affairs
7 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAs our Senior Manager EU/ROW Regulatory Affairs, you'll be responsible for ensuring that our regulatory affairs functions are operating effectively and efficiently. This includes representing RA in clinical trial teams, ensuring regulatory oversight and progress of multiple clinical trial submission activities, and representing EU/ROW in the Global...
-
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeRadiobotics is a dynamic and innovative company dedicated to solving the global need for radiologists while ensuring every patient receives expert-level care. We are looking for a talented QA/RA specialist to join our Clinical and Regulatory team and contribute to our mission.The ideal candidate will have a strong background in quality assurance and...
-
Director of Regulatory Affairs
4 days ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeThe Director of Regulatory Affairs ensures that the company's products meet global regulatory requirements, focusing on the USA and Europe, including those set by the FDA, EMA, and other relevant authorities. This role is responsible for developing and executing regulatory compliance strategies, navigating approval processes for pharmaceuticals and medical...
-
Regulatory Affairs Project Lead Position
3 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we are committed to pushing the boundaries of cancer treatment through innovative therapies. As a key member of our Global Regulatory Affairs organization, you will play a vital role in developing and executing EU/ROW regulatory strategies for our compounds.">The Role & DepartmentYou will join our dynamic team as an (Associate) Director, Global...
-
Senior Regulatory Affairs Professional
1 day ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout This OpportunityWe're looking for an experienced Senior Regulatory Affairs Professional to join our team at Genmab. As a key member of our Global Regulatory Affairs organization, you'll play a critical role in developing and executing the EU/ROW regulatory strategy for assigned projects. Your expertise will be essential in ensuring regulatory...
-
Regulatory Affairs Project Lead
1 day ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout GenmabAt Genmab, we're a biotechnology company with a mission to transform the lives of patients through innovative cancer treatment and therapies. We're driven by our core purpose to strive towards improving patient outcomes with next-generation antibody technology platforms and translational research. Our team is passionate about developing...
-
Regulatory Affairs Director
7 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob RoleThe Director/Associate Director, Global Regulatory Affairs will provide strategic regulatory guidance on CMC topics, collaborate with cross-functional peers, and plan and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.This role requires strong leadership and...
-
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeWe are seeking a highly skilled Senior Manager of Regulatory Processes and Tools to join our Global Regulatory Affairs team. In this role, you will be responsible for driving process improvements and implementing systems and tools within Regulatory Affairs to support efficient regulatory support for the organization and growth of the company.This position is...