Director, Head of Regulatory Operations

Does it excite you to work with regulatory operations excellence and digital enablement, and do you have experience with building scalable regulatory processes, data management and Veeva RIM? 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 Director, Head of Regulatory Operations, you will establish and lead a new department that drives high-quality, efficient regulatory operations across Zealand Pharma’s portfolio. You will define strategies, standards and systems that enable timely, compliant submissions and transparent ways of working. As a member of the Regulatory Affairs management team, you will help set direction and ensure successful execution of regulatory strategies. Your work will enable innovative medicines to reach patients faster through smart process design, robust data foundations and fit-for-purpose technology.

We offer exciting responsibilities:

• Build and lead the new Regulatory Operations department, including talent development and team growth
• Define and standardize regulatory data and document management, including XEVMPD/IDMP data for development and marketed products
• Own and evolve regulatory process management to ensure efficiency, compliance and on-time execution across the portfolio
• Serve as Veeva RIM Submission process owner; optimize configuration, governance and adoption to ensure fit-for-purpose use
• Monitor and assure compliance with regulatory deadlines and quality requirements; drive continuous improvement
• Evaluate, implement and govern regulatory IT solutions; unlock AI use cases to enhance effectiveness and cycle-time reduction

Your profile
An inclusive, collaborative leader with a structured and forward-looking mindset. Adept at translating regulatory requirements into scalable processes and data models. Comfortable with operating at strategic and operational levels, with strong digital acumen and a passion for innovation and continuous improvement.

• Master’s degree in Life Science, Health Science, or related field
• Several years of regulatory experience in a similar role within pharma or a Health Authority
• Proven experience managing a department/team and developing people
• Strong IT/digital skills; hands-on experience with Veeva Vault, preferably Veeva RIM
• Proficiency in English (written and spoken)
• Ability to reimagine processes and apply regulatory requirements in new frameworks (process, data, IT, AI)
• Open-minded, engaged, and team-oriented; strong stakeholder management skills

Your new team
You will lead the newly established Regulatory Operations department within Regulatory Affairs, working closely with colleagues across development, quality, clinical, CMC, and other key functions to enable compliant, efficient regulatory execution. As part of the Regulatory Affairs management team, you will contribute to the overall strategy and operating model for the function.

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 November 16, 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 Christina Balslev Rindshøj, Vice President, Head of Regulatory Affairs: chr@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.