Regulatory Manager

København S, DK, 2300 Job ID: 23315 Are you passionate about navigating regulatory changes and staying ahead of the regulatory trends? We are seeking a dynamic Regulatory Manager to join our team and support our organization in analyzing the impact of upcoming EU and local Nordic regulatory changes. At Nordea, we're committed to being a partner our...

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...

Innovative solutions for a better tomorrowRadiometer Danmark / Danaher is committed to improving global healthcare with reliable, fast, and easy patient diagnoses. We strive to make a difference in people's lives by providing cutting-edge technology and solutions.The Senior Manager, RA Processes, Systems and Tools plays a crucial role in driving process...

Nordea's commitment to regulatory excellence is reflected in its dedication to fostering a collaborative environment where employees can thrive. As a Regulatory Manager, you will be part of a dynamic team focused on staying ahead of regulatory trends and ensuring seamless compliance.In this critical role, you will be responsible for:Identifying and...

Are you passionate about quality assurance? Do you have experience working in pharmaceutical operations?Job DescriptionAs a Regulatory Compliance Manager at QCS Staffing, you will play a key role in ensuring compliance with regulatory requirements. You will work closely with the PQA team to coordinate internal and external audits, develop and implement...

Job SummaryAs a Regulatory Manager in our Global Affairs department, you will be responsible for supporting the Global Regulatory Lead and/or Regional Regulatory Lead in the preparation of regulatory documentation and submissions to health authorities.You will work closely with cross-functional teams to ensure timely input and delivery of high-quality...

Key ResponsibilitiesThe successful candidate will be responsible for:Supporting the Head of Delegated Authority Operations and Controls in ensuring the effective oversight of delegated activities.Managing the onboarding process for new Coverholders and DCAs, ensuring compliance with regulatory requirements.Collaborating with the Delegated Audit Manager to...

Genmab A/S is looking for a highly motivated and experienced Regulatory Manager to join our Global Affairs team. In this role, you will be responsible for supporting the Global Regulatory Lead and/or Regional Regulatory Lead in the preparation of regulatory documentation and submissions to health authorities.You will work closely with cross-functional teams...

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...

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...

About UsAt Black Swans Exist, we're passionate about revolutionizing microbiome-based therapies for women's reproductive health. Our mission is to develop innovative biologics and combination drug-device products that transform lives.The JobWe're seeking a highly experienced Director of Regulatory Affairs to lead our global regulatory strategies. As a key...

Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative and differentiated antibody therapeutics. Our team has invented next-generation antibody technology platforms and leveraged translational research and data sciences to create a proprietary pipeline including bispecific T-cell engagers,...

We are seeking a Regulatory Compliance Manager to join our team at Jefferson Wells Manpower Group.About the JobThis role is responsible for ensuring that all affiliate operations comply with local legislation and GDP requirements. The ideal candidate will have strong analytical skills and be able to interpret complex regulations.Main DutiesRegulatory...

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...

As a Compliance Manager - Regulatory Affairs, you will be responsible for handling change controls and deviations in GxP validated IT Systems. You will also act as an expert, ensuring compliance with regulatory guidelines and providing guidance on national and EU legislation within the regulatory field.About UsSandoz, a leader in generic and biosimilar...

Black Swans Exist is seeking a highly experienced Regulatory Affairs Director to join its team. As a key member of the organization, this individual will be responsible for developing and executing regulatory compliance strategies. This role requires a strong understanding of regulatory requirements and the ability to navigate approval processes for...

Key QualificationsWe are seeking a highly skilled and experienced leader to be our Head of Global Product Stewardship and lead our dynamic Product Stewardship team.The ideal candidate will have a deep understanding of global chemical regulations, a passion for Product Stewardship and Chemicals Management, and the expertise to guide our company through this...

Drive meaningful change in Regulatory Marketing AuthorizationIn Regulatory, we obtain licenses for parallel trading of medicine. We do this by submitting applications to the European Medicines Agency and national medicine agencies of our sales countries.Our department is responsible for making sure that Abacus Medicine can parallel trade medicines as fast as...

Job SummaryWe are seeking a highly skilled Senior Manager to lead our Regulatory Affairs team in driving process improvements and implementing systems and tools to support efficient regulatory support. As a key member of the Global Regulatory Affairs team, you will be responsible for overseeing a team of highly engaged associates and focusing on their...

As a Regulatory Compliance Manager at QCS Staffing, you will play a crucial role in supporting their pharmaceutical client in Copenhagen, Denmark.About the JobThis 6-month contract position involves overseeing the effective operation of the Quality Management System, ensuring compliance with ISO standards. Key responsibilities include:Managing and enhancing...