Regulatory Project Director - Clinical

Job description

Does it excite you to shape regulatory strategies for early-stage metabolic health projects, and do you have experience leading global regulatory strategy 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 Regulatory Project Director - Clinical, you will be the global regulatory lead for early-stage projects within metabolic health. You will define and drive regulatory strategies from prior to first-in-human through early clinical development and represent Regulatory Affairs in cross-functional project teams. The position offers a high degree of ownership and the opportunity to influence how new peptide-based medicines move from concept to clinic. We offer exciting responsibilities: Act as regulatory lead for assigned early-stage projects and serve as a member of the Global Project Team member Develop regulatory strategies, including plans for health authority interactions and input to project development plans Lead health authority interactions end-to-end and ensure timely, high-quality responses to agency queries Lead regulatory submissions and submission teams, and review scientific documents to ensure regulatory standards are met Provide regulatory intelligence and regulatory input to business plans and in- or out-licensing opportunities Manage regulatory consultants, CROs and partners, and provide professional guidance to regulatory clinical and documentation specialists Your profile You have an innovative mindset combined with solid leadership skills and the ability to influence all levels of the organization. You build trust across functions, communicate clearly with both internal stakeholders and regulators, and take ownership of delivering results. You are curious, pragmatic and comfortable making decisions in the face of uncertainty. Master's degree in life science Extensive experience in Regulatory Affairs, including several years as RA Lead Experience developing global regulatory strategies, including interactions with health authorities Experience with due diligence activities Solid understanding of science and drug development Your new team You will join Regulatory Affairs as part of the RA Clinical team, which is responsible for early-stage projects within metabolic health, and the rare diseases projects. You will report to the Senior Director, Head of RA Clinical, and work closely with colleagues across Clinical Development, CMC, Non-clinical, Quality and Project Management. 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 23, 2026 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 Senior Director, Head of RA Clinical, Lisbeth Lyme, llyme@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 advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data-driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma-invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com. #LI-Onsite