Regulatory Affairs CMC (Senior) Specialist

Be the new Regulatory Affairs CMC (Senior) Specialist In a biotech company bonding to discover, design and develop innovative peptide-based medicines. Are you experienced in regulatory affairs CMC with an interest in working with combination products? 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 Regulatory Affairs CMC (Senior) 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 23 employees. In RA CMC and Device you will work with internal stakeholders across the whole organization, as well as external stakeholders from different contract manufacturing organizations (CMO’s) and contract research organizations through all phases of product development and life cycle management (LCM). 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 RA CMC (Senior) specialist you will be responsible for one of our late-stage projects progressing towards NDA and MAA submission. Responsibilities Provide regulatory strategic CMC guidance, regulatory intelligence and execute operational tasks and submissions for assigned R&D project(s) and products (LCM), including Q&A with relevant authorities.  Work with CMO’s and partners on the above-mentioned tasks.  Drive regulatory authority interactions on the CMC part. Be involved in the preparation for 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 in Regulatory Affairs CMC with >5 years’ experience from a similar position in Regulatory Affairs CMC. Strong knowledge of CMC regulatory requirements and processes during clinical development and/or life cycle management. Experience with regulatory authority interactions.  Ideally knowledge of device requirements for combination products. Collaborator with a relentless focus on creating results as a team.  Strong writing and communication skills. Strategic thinker with a proactive and results-driven approach. Ability to thrive in a fast-paced environment and manage multiple priorities. 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 April 27, 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. Since our founding in 1998, Zealand Pharma has built a core expertise in the discovery, design, and development of therapeutic peptides. This expertise has led to an R&D pipeline of innovative investigational candidates designed to address a broad range of disease areas. We have four therapeutic focus areas: obesity, rare diseases, chronic inflammation, and type 1 diabetes. In obesity, our peptide capabilities place us in a unique position to address a vast global health challenge and positively impact hundreds of millions of lives. Within rare diseases, we have a long-standing commitment to deliver new treatments to patients living with congenital hyperinsulinism and short bowel syndrome. For chronic inflammatory diseases, we are progressing peptide programs focused on high-profile targets shown to be difficult to address with small molecules and antibodies. For type 1 diabetes, we aspire to change the management of this disease. Our strategy is to pursue global co-development and commercialization partnerships that complement and extend our capabilities across the value chain to deliver new peptide therapies to people who need them.