Regulatory Affairs CMC Manager — Global Vaccine Strategy

Bavarian Nordic; Kvistgård; On-site; DKK 1,100,000 - 1,400,000; Full time

Benefits offered by this job

Flexible work environment

Professional development opportunities

Visa sponsorship not available

Job summary

Bavarian Nordic is seeking a Regulatory Affairs CMC Manager to drive global CMC regulatory strategies for our vaccine portfolio. You will coordinate across R&D and Global Operations, guiding submissions to health authorities and ensuring lifecycle regulatory readiness.

Based in Kvistgård, you will lead a small team, collaborate with cross-functional partners, and travel occasionally as needed to support registration efforts and global market expansion.

Qualifications

• Master's or doctoral degree in a scientific discipline relevant to vaccines.
• Approximately 8+ years of regulatory affairs experience in pharma/biotech/vaccine industry.
• Strong track record with global regulatory submissions and health authorities.
• Experience with CMC regulatory activities for biologics or vaccines.

Responsibilities

• Lead CMC regulatory strategies and submissions to enable vaccine registrations in new markets.
• Prepare and maintain high-quality regulatory documentation for health authorities.
• Provide regulatory direction across R&D and Global Operations and coordinate cross-functional activities.
• Interact with global health authorities alongside the Global Regulatory Lead.
• Drive lifecycle regulatory activities including changes in manufacturing or process.

Skills

Regulatory affairs

Global regulatory submissions

Project management

Scientific writing

English proficiency

Education

MSc or PhD in Pharmacy/ Biotechnology/ Chemistry/ Biology/ Biochemistry/ Chemical Engineering

Job description

Bavarian Nordic is seeking a Regulatory Affairs CMC Manager to drive global CMC regulatory strategies for our vaccine portfolio. You will coordinate across R&D and Global Operations, guiding submissions to health authorities and ensuring lifecycle regulatory readiness.

Based in Kvistgård, you will lead a small team, collaborate with cross-functional partners, and travel occasionally as needed to support registration efforts and global market expansion.