Global CMC Regulatory Lead, Vaccines (Hybrid)

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

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.