xDo you have a talent for navigating complex regulatory landscapes and driving strategic initiatives? Are you eager to contribute to the rapid development of a high impact program?If you are passionate about regulatory science and committed to bringing innovative medicines to market, then we invite you to apply and join [xxxxx] as a Regulatory Affairs Professional.Your new roleAs a Regulatory Affairs Professional you will be working within the RA Diabetes, CV, Liver and Rare Disease therapeutic area on several early development projects approaching phase 1 clinical trials. You will belong to one team but also support other teams on similar tasks and be responsible for driving several regulatory tasks with challenging and often overlapping timelines. Therefore, this role entails interactions with various stakeholders throughout the organization.Your responsibilities may include:
Contribute with regulatory expertise to global strategies and tacticsDevelop regulatory documentation for submission to Health Authorities globally, e.g. clinical trial applications, briefing packages, paediatric plans, and responses to health authority questionsRepresent Regulatory Affairs in global clinical trial teams and other cross-functional teamsCollaborate effectively with cross-functional stakeholders such as project managers, medical and non-medical specialists, statisticians, and medical writersYour new department RA Diabetes, CV, Liver and Rare Disease is an area within Regulatory, Quality & Clinical Reporting consisting almost 100 dedicated and highly engaged Global Regulatory Leads, Regulatory Specialists and Professionals, organised in eight teams. Our area is charged with developing and executing on global regulatory strategies. These strategies are designed to advance projects across multiple indications, from the early stages of development through to worldwide submission and approval of initial Marketing Authorisation applications.We are responsible for driving label development, facilitating interactions with health authorities, and overseeing regulatory submissions. These submissions include initial marketing authorisation applications, paediatric plans, and clinical trial applications. We maintain strong ties with our affiliates and global stakeholders, fostering a close collaboration that is integral to our operations.Your skills and qualificationsTo thrive and succeed in this position you should preferably have:A master’s degree or PhD within Life Science, Health Science, or a related field Solid and hands-on regulatory and/or drug development experienceExperience from working on clinical development programs is an advantage Advanced communication skills in both written and spoken EnglishStrong IT/digital skillsPersonally, you thrive in fast-paced, collaborative environments and actively contribute to the team's success. You should be well-organised, possess robust problem-solving capabilities, and maintain a strategic focus. A positive, can-do attitude is crucial, as is the ability to keep your spirits high and maintain a healthy sense of humour under pressure.Working at [xxxxx] We're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today. The video below features colleagues worldwide speaking about why they’re proud to work at [xxxxx] and highlights the culture, collaboration and long-term impact. Together, for the long-term!What we offer At [xxxxx], you’ll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage.Salary: For this role, the Annual Base Salary ranges from DKK 570,200 to DKK 838,100 (DK), corresponding to the level of the position.The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.Incentives and Benefits: The salary package may include short-term as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.Learn more about our Reward Philosophy here.ContactFor further information, please contact Jenny Kastberg at [xxxxx] mayYou do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Please assist us in maintaining a fair and inclusive selection process by not attaching a photo to your application...
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 6.5.2026, men kan have været deaktiveret og genaktiveret igen.
