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 Senior Manager of Regulatory Affairs, CMC Reporting to the Senior Director of Regulatory Affairs, CMC, you will be responsible for regulatory CMC activities related to the new product (launch in 2025) and sharing accountability about this product. The position can be located either in Kvistgaard or Bern.

The roleIn this leadership role, you will manage a team of two and oversee the development and lifecycle management (LCM) activities, ensuring effective prioritization and alignment with strategic goals. You will drive product CMC submission strategies and lead the preparation of Scientific Advice (SA) packages and presentations for the product. You will facilitate cross-organizational alignment and act as a regulatory sparring partner for the team and the broader CMC organization.

It is important that you take ownership of RA CMC procedures, maintain oversight of the evolving regulatory environment, and drive complex submissions. Collaboration with internal and external stakeholders and utilizing your professional expertise to set departmental goals that align with functional strategies and support overall success are also part of the role.

Skills and requirementsYou hold a master's degree or Ph.D. in biological sciences or a related field. This pivotal role demands over 8 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.

Additionally, you bring extensive experience and a deep understanding of the drug development process for vaccines, including manufacturing and regulatory requirements, with an emphasis on late-stage clinical development and commercialized products. Strong strategic thinking, effective communication, team leadership, project management, and CMC authoring skills are essential for this role.

You will also contribute to corporate initiatives by embodying the Bavarian Nordic DNA, fostering employee engagement, and embracing change.

Fluency in either Danish or German is a must.

We offerAs Senior Manager, you will have the opportunity to make a solid impact on the maturation of our new product within RA.

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.

Caught your interest?

Please contact Senior Director Rehana Mukhtar via Write an email, if you have any questions regarding the position.

Applications submitted via email will not be considered but must be submitted through our designated application platform.

We kindly request that headhunters or recruitment agencies refrain from contacting us regarding this position

Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values - our Bavarian Nordic DNA, as we like to call it - are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer.

Bavarian Nordic

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