Be the new Senior (or Principal) Regulatory Affairs Device Specialist
In a biotech company bonding to discover, design and develop innovative peptide-based medicines.
Are you experienced in regulatory affairs combination product device requirements? Are you motivated by defining regulatory strategies, balancing opportunities and risks and succeeding as part of cross-functional teams? Do you thrive in an informal environment, approach challenges with curiosity and a positive mindset?
If this sounds like you, and you are ready to take on a broad area of responsibilities with an independent attitude, you are a match for us.
Currently, we are looking for a new Senior (or Principal) Regulatory Affairs Device Specialist to join the Regulatory (RA) CMC and Device department. Zealand Pharma is growing tremendously, and the RA CMC and Device department is as well, and we are therefore looking for a new colleague to join our team currently consisting of 5 RA CMC & Device Specialists. The department is part of the RA area consisting of 22 employees. In RA CMC and Device you will work with many different internal as well as external stakeholders, including different contract manufacturing organizations (CMO’s) and contract research organizations. The environment is informal, and curiosity, questioning how things can be done to define optimal strategies, succeeding as a team while also having fun are values, we strive to embed in everything we do. As the new Senior (or Principal) RA Device Specialist you will be responsible for the device constituent’s aspects of one or more of our development projects, spanning from phase 2 to late-stage development and NDA/MAA approvals and LCM activities.
Responsibilities
- Provide regulatory strategic device guidance, regulatory intelligence and execute operational tasks and submissions for assigned development project(s) and products (LCM), including Q&A with relevant authorities
- Work with internal stakeholders, CMO’s and partners on the above-mentioned tasks
- Drive regulatory authority interactions on the device constituent part
- Stay informed about changes in device regulations, standards and guidelines, supporting that best practice are implemented
- Be involved in regulatory authority inspections, as applicable
- Provide regulatory input to due diligence exercises, as applicable
- Proactively contribute to the development of the department, incl sharing better practice, and optimizing how we work
Candidate profile
- Academic degree (MSc/PhD) in a health-related or scientific discipline
- Experienced Regulatory Affairs device specialist with a track record of moving combination products through various stages of development, including experience with regulatory authority interactions
- Experience with regulatory authority interactions and notified bodies
- Collaborator with a relentless focus on creating results as a team
- Strategic thinker with a proactive and results-driven approach
- Motivated by contributing to a close collaboration between CMC and device development, understanding the interfaces between the drug and the device constituent
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 August 26, 2025, or as soon as possible. The applications will be reviewed as they come in.
For further information, please contact Barbara Hee Schmidt, Director, Head of Regulatory CMC and Device at BSchmidt@zealandpharma.com.
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.