Director Regulatory Affairs, CMC

About Bavarian Nordic

At Bavarian Nordic, we are committed to saving and improving lives by unlocking the power of the immune system. Our commercial product portfolio includes market-leading vaccines against smallpox, mpox, rabies, tick-borne encephalitis, typhoid fever, and cholera. We excel in R&D innovation, manufacturing, and commercialization, striving to improve people's health and quality of life worldwide, protecting our tomorrow. Join us in our mission to make a difference.

As part of our growth journey, we seek a Director Regulatory Affairs, CMC for a role which combines leadership and being responsible for one early-stage development product. In this role, you will report to the Senior Director of Regulatory Affairs, CMC and you will be a strategic support for different projects and agency collaboration. The position is located in Kvistgaard.

The Role of Director Regulatory Affairs, CMC

In this role, you will lead a small team working with Post Authorization activities, ensuring the successful execution of lifecycle management (LCM) activities for the related products. You will be accountable for the submission and approval of all LCM initiatives, prioritizing activities that safeguard business continuity and adapting regulatory strategies for major submissions as the landscape evolves.

You will provide strategic support for key projects, as well as operational guidance to ensure business continuity for relevant markets. Additionally, you will ensure compliance with Regulatory CMC and combination product requirements in line with applicable regulations.

The position also involves contributing to budget planning and administration, while building foundational knowledge of combination products. Your expertise will help shape regulatory strategies and maintain compliance standards, supporting both short-term operational needs and long-term business objectives. Other relevant responsibilities include:

• Budget input
• Cross organizational involvement and alignment
• Regulatory sparring partner for the team and the CMC organization
• Utilize in-depth professional knowledge and experience to set departmental goals which align with functional strategy

Skills and Requirements

You hold a master’s degree or Ph.D. in biological sciences or a related field. This pivotal role demands over +10 years of experience in Regulatory Affairs, with a strong focus on biologics, coupled with leadership and management expertise.

Success in this position requires a curious, analytical mindset and a problem-solving approach. You excel at breaking down large projects into manageable tasks and navigating challenges effectively. For this role, we are looking for someone who is strong at ‘thinking out of the box’.

Additionally, you bring extensive experience and a deep understanding of the drug development process for vaccines or biologics, including manufacturing and regulatory requirements, with an emphasis on early-stage clinical development and commercialized products.

You will also contribute to corporate initiatives by embodying the Bavarian Nordic DNA, fostering employee engagement, and embracing change. Strong strategic thinking, effective communication, team leadership, project management, and CMC authoring skills are essential for this role.

Fluency in Danish is an advantage.

What We Offer

This role offers a unique opportunity to make a meaningful impact on global health by ensuring the lifecycle management and regulatory compliance of critical vaccines. You will shape regulatory strategies for major submissions, drive high-impact projects, and provide strategic support during operational challenges preventing stock-out situations. Working cross-functionally, you’ll influence business continuity, expand your expertise in combination products and CMC compliance, and contribute to innovation in a dynamic regulatory environment.

If you thrive in a strategic, fast-paced setting and want your work to directly support the availability of life-saving vaccines worldwide, this position is for you.

You will work in an international company with unique technology and a dedicated workforce. We welcome people who share our passion for making a difference. We offer a dynamic and flexible work environment and an opportunity to develop your personal and academic competencies.

Key skills/competency

• Regulatory Affairs
• CMC Compliance
• Lifecycle Management
• Biologics & Vaccines
• Leadership
• Strategic Thinking
• Project Management
• Drug Development
• Regulatory Submissions
• Combination Products