Does it excite you to work with regulatory strategy in clinical development, and do you have experience with global submissions and health authority interactions? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague.
Your new position
As a (Senior) Regulatory Affairs Clinical Specialist, you will provide regulatory input and direction across clinical development programs. Partnering closely with cross-functional teams, you will help navigate evolving regulatory requirements and enable timely, high-quality submissions. This role combines strategic thinking with hands-on execution to support development plans that bring innovative peptide-based medicines to patients.
We offer exciting responsibilities:
- Provide regulatory expertise and guidance in global development projects
- Act as regulatory lead in clinical trial teams across planning, execution and 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
Your profile
You bring sound regulatory judgment, a structured approach, and the ability to translate complex requirements into clear plans. A collaborative mindset and strong communication skills enable effective teamwork in a fast-paced, solution-oriented environment focused on patient impact.
- Master's degree within Life Science, Health Science, or a related area
- Several years of regulatory experience in a similar role, 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
Your new team
You will join the Regulatory Affairs function, collaborating closely with clinical development and adjacent disciplines to advance Zealand Pharma’s pipeline. The team is characterized by strong teamwork, knowledge-sharing, and a high level of engagement to deliver on global development goals.
Let's bond and be bold
We have a unique culture, characterized by excellent teamwork and strong engagement across the organization. And we want you to help us strengthen this culture.
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 through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Join us and let's bond and be bold.
Interested in bonding with us? Then please apply no later than December 5, 2025, or as soon as possible. The applications will be reviewed as they come in. While a cover letter is not required, please include a few sentences in your CV explaining your motivation for applying.
For further information, please contact Director, Head of RA Clinical, Susanne Lund Olsen; slolsen@zealandpharma.com.
We are committed to an inclusive recruitment process and welcome applications from all job applicants.
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 team in the U.S. For more information about Zealand Pharma's business and activities, please visit www.zealandpharma.com.
