Do you want to be part of an exciting environment where engaged people are committed to optimize [xxxxx]’s medicines across the globe? Would you like to join a team with a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders? If yes, join us as a Regulatory Affairs Specialist. Regulatory Affairs (RA) is a truly interesting and challenging place to work, so apply today!Your new roleAs Regulatory Affairs Specialist, you will be responsible for developing regulatory strategies and lead their execution via interaction with cross-functional teams. You will lead, drive and coordinate several regulatory activities related to the [xxxxx] RA Rare Bleeding Disorders portfolio. This will entail close collaboration with the Global Regulatory Lead.Your main responsibilities will include:
Contributing with regulatory expertise to global strategies and tactics, by analysing regulatory opportunities and risksLeading major submission tracks such as briefing packages for meetings with Health Authorities, clinical trial applications, and global submission strategies, working with affiliates to ensure alignment between local and global regulatory strategies and timely preparation of documentationYou will report to the head of the department and take active part in department related activities, including improvement projects across RA.Your new departmentRA Rare Bleeding Disorders department is part of Global Regulatory Affairs and situated in Søborg, Denmark. We are contributing to the development of different products and projects within Rare Bleeding Disorders with a pipeline including a variety of different modalities and technologies including gene therapy.We are a department with 14 dedicated and highly engaged employees of 8 different nationalities with diverse backgrounds and experiences. We work in a flexible set-up where trust & openness, sparring, challenge and knowledge sharing fosters an inclusive and innovative culture we all enjoy being part of. While flexible work is valued, the job requires physical presence to enable effective discussion, knowledge sharing, and strong team connections. We work as an integrated part of the global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and provide regulatory expertise and tactics to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications.Your skills & qualificationsWe are looking for a person with a strong regulatory and scientific foundation who can contribute effectively to global regulatory activities. You should be able to work independently within a cross-functional environment and demonstrate sound decision-making based on regulatory principles.To succeed in this role, you bring:A master’s degree or Ph.D. in science, pharmaceutical or health scienceMinimum 7-8 years of experience in Regulatory Affairs or other relevant area in drug developmentPractical knowledge in defining and developing global regulatory strategies and good all-around understanding of the regulatory documentation and requirements for pharmaceutical development and licensingExcellent project management skills and ability to cooperate at any organizational levelChange-oriented approach and a willingness to experimentAbility to quickly learn and navigate new digital solutions and regulatory databases to support submission processes and cross-functional collaborationStrong communication skills in verbal and written EnglishOn a personal level, you bring a proactive and positive approach, communicate effectively across the organization and work well in dynamic situations. You are comfortable sharing your perspective, approaching challenges with curiosity and flexibility, and taking ownership of your work and continuous development. You stay focused under pressure, adapt to change with ease and contribute constructively to collaborative problem-solving. You are proficient in common IT tools and systems relevant to regulatory affairs, including Microsoft Office and electronic document management platformsWorking 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 742,600.00 to 1,091,600.00 DKK, 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 and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.
Learn more about our Reward Philosophy here.
Deadline
15th of May 2026. We are looking to hire more than one candidate, with roles available at multiple levels of seniority.
Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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 1.5.2026, men kan have været deaktiveret og genaktiveret igen.
