Senior (or Principal) Regulatory Affairs CMC Specialist

Be the new Senior (or Principal) Regulatory Affairs CMC 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 Senior (or Principal) Regulatory Affairs CMC Specialist to join the Regulatory (RA) CMC and Device department. Zealand Pharma is growing, 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 CMC Specialist you will be responsible for the CMC aspects of one or more of our development projects, spanning from early to late-stage development and NDA/MAA approvals and LCM activities.

Responsibilities

• Provide regulatory strategic CMC 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 CMC part
• 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 CMC specialist with a track record of moving products through various stages of development, including experience with regulatory authority interactions
• Strong knowledge of CMC regulatory requirements and processes during clinical development and/or life cycle management
• 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