Be our new Regulatory Affairs Clinical Specialist
In a biotech company bonding to discover, design and develop innovative peptide-based medicines.
We are expanding our Regulatory Affairs team due to many activities in our exciting clinical development projects and are seeking a new colleague for our Regulatory Affairs function.
As a (Senior) Regulatory Affairs Clinical Specialist, you will play a critical role in providing regulatory input and direction throughout the clinical development process. You will collaborate closely with cross-functional teams to navigate the complex regulatory landscapes and contribute to the successful execution of the regulatory strategies within clinical development. Your expertise will be instrumental in maintaining adherence to regulatory standards while facilitating the advancement of innovative medicinal products making a difference to patients.
Responsibilities
- Provide regulatory expertise and guidance in global development projects
- Act as regulatory lead in clinical trial teams (planning, execution, reporting)
- Contribute to EU MAA and US NDA documentation and submissions
- Support health authority interactions and Q&A strategies
- Collaborate cross-functionally with regulatory, clinical, non-clinical, and writing teams
- Monitor new legislation, guidelines, and industry trends in clinical development
- Drive process and improvement initiatives within Regulatory Affairs and across the company
Candidate profile
- Master's degree within Life Science, Health Science, or a related area
- Several years of regulatory experience in a similar position, from the pharmaceutical industry or Health Authority
- Experience of working on projects in the clinical development phase
- Strong IT/digital skills and experience with Veeva Vault
- Open to diverse perspectives and ability to demonstrate engagement through collaboration
Bonding to innovate
Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other.
We bond as a result of our entrepreneurial culture where our people are encouraged to pursue their ideas and turn them into reality. We are curious about each other’s knowledge and expertise.
We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Zealand Pharma is a place where everyone is heard and contributes to the success, we all want to experience.
The Zealand Pharma DNA builds on four values: (1) We are bold, (2) We empower people, (3) We work as one team, and (4) We can be trusted.
Let’s bond and be bold
We offer a combined compensation package which includes a base salary, pension, bonus, and a possibility to join our employee share program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities,
To find out more about working at Zealand, visit https://www.zealandpharma.com/careers/zealand-as-a-workplace/
Interested? Please apply no later than September 21, 2025, or as soon as possible. The applications will be reviewed as they come in.
For further information, please contact Susanne Lund Olsen, Director, Head of Regulatory Affairs Clinical at [email protected]
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand Pharma have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products.
Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand Pharma’s business and activities, please visit www.zealandpharma.com
