Regulatory Affairs CMC Manager

Bavarian Nordic; Rom By; Hybrid; DKK 673,000 - 897,000; Full time

Job summary

Bavarian Nordic invites a Regulatory Affairs CMC Manager to shape global CMC strategies for our vaccine portfolio from Kvistgaard. You will drive regulatory submissions across markets, coordinating with R&D and Global Operations to ensure timely approvals and lifecycle management.

The role requires 8+ years in Regulatory Affairs, strong experience with global submissions, and excellent scientific writing in English. Occasional travel is expected as part of a dynamic, international team.

Qualifications

• 8+ years of experience in Regulatory Affairs within pharma, biotech or vaccines.
• Experience with global regulatory submissions and health authorities.
• CMC regulatory activities for biologics, vaccines or complex products.
• Excellent scientific writing and authoring skills.

Responsibilities

• Lead regulatory CMC strategies and submissions for new markets.
• Prepare and maintain regulatory documentation for health authorities submissions.
• Act as regulatory partner to cross-functional teams and provide regulatory guidance.
• Manage interactions with global health authorities and prepare briefing materials.

Skills

Regulatory affairs

Scientific writing

Project management

English fluency

Education

MSc or PhD in Pharmacy/Biotech/chemistry

Job description

## Regulatory Affairs CMC ManagerApply: Hybrid (remote and on-site): Kvistgaard: Full time: Posted 2 Days Ago: JR101538Are you passionate about regulatory affairs and bringing innovative vaccines to patients worldwide? Would you like to shape global CMC strategies and support the expansion of our life-saving vaccines?Then you could be our next Regulatory Affairs CMC Manager. 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, cholera, and chikungunya. We excel in R&D innovation, manufacturing, and commercialization, striving to improve people's health and quality of life worldwide while protecting our tomorrow. **The role**Your primary focus will be the continued global expansion of our chikungunya vaccine following its initial approvals in the US and Europe. You will play an important role in shaping the regulatory approach for new markets and supporting the vaccine throughout its lifecycle. Working across R&D and Global Operations, you will provide clear regulatory direction, coordinate activities across functions, and help move complex regulatory priorities forward. As Regulatory Affairs CMC Manager, you will join a skilled team of three colleagues responsible for global CMC regulatory activities. Based in Kvistgaard, you will report to the Senior Manager, Regulatory Affairs CMC. Occasional travel should be expected. **Your key responsibilities*** Lead regulatory CMC strategies and submissions that enable our vaccines to be registered and launched in new countries worldwide* Prepare and maintain high-quality scientific and regulatory documentation to support submissions to health authorities* Act as a trusted regulatory partner to cross-functional teams, providing guidance on regulatory requirements and submission expectations* Manage interactions together with the Global Regulatory Lead with global health authorities, including preparation of briefing materials and responses to regulatory questions* Drive regulatory activities throughout the product lifecycle, ensuring that manufacturing, process, or product changes are effectively implemented and approved in global markets **What we are looking for**You hold an MSc or PhD in a scientific discipline such as Pharmacy, Biotechnology, Chemistry, Biology, Biochemistry, Chemical Engineering, or a related field. In addition, you bring:* Approximately 8+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or vaccine industry* Strong experience with global regulatory submissions and international health authorities* Experience with CMC regulatory activities for biologics, vaccines, or complex pharmaceutical products* Solid understanding of pharmaceutical development, manufacturing, and regulatory requirements* Excellent scientific writing and authoring skills* Strong project management and planning capabilities* Fluency in written and spoken English **Who you are**To succeed in this role, you are:* A collaborative team player who enjoys working across functions and cultures* Detail-oriented and able to manage complex documentation with a high level of accuracy* Proactive, agile, and comfortable navigating changing priorities* A strong stakeholder manager who can build trusted relationships across the organization* Curious, solution-oriented, and motivated by making a global impact **What we offer**You will join an international vaccine company with unique technology, dedicated colleagues, and a collaborative culture built on teamwork, openness, and scientific excellence. We offer a flexible work environment, opportunities for professional development, and the chance to contribute to work with a meaningful global impact. **Caught your interest?**If you are ready to shape global regulatory strategies and help bring innovative vaccines to more patients worldwide, apply through our designated application platform. Applications submitted by email will not be considered. Please note that visa sponsorship and relocation assistance are not available for this position.