Strategic Global Regulatory Affairs Manager, Biologics

Bavarian Nordic; Köniz; On-site; CHF 120,000 - 170,000; Full time

Job summary

Bavarian Nordic is seeking a Regulatory Affairs Manager to lead global regulatory activities across product registration and lifecycle management. You will work with cross-functional teams and health authorities to shape regulatory strategies and submissions, with occasional travel to partner sites.

The role requires a Master’s in Life Sciences and a minimum of five years in Regulatory Affairs within pharma drug development. Strong EU/US knowledge and English fluency are essential.

Qualifications

• Master’s degree in Life Sciences or related field.
• Minimum of 5 years Regulatory Affairs experience in pharmaceutical drug development, global environment.
• Strong understanding of EU/US regulatory submission and approval processes.
• Ideally experience with biologics registration and lifecycle management.
• Excellent communication and stakeholder management; fluent in English.
• Detail-oriented with strong analytical skills; able to translate data into regulatory documentation.

Responsibilities

• Lead regulatory activities for lifecycle management projects and global expansions.
• Develop and execute regulatory strategies for post-approval activities.
• Prepare, coordinate and submit high-quality regulatory documentation and submissions.
• Act as RA lead within cross-functional project teams and provide strategic guidance.
• Coordinate responses to health authority questions and regulatory reviews.
• Monitor evolving regulatory requirements and communicate updates to stakeholders.
• Contribute to regulatory operational excellence and SOP development.

Skills

Regulatory affairs

Stakeholder management

English fluency

Analytical skills

Regulatory documentation

Education

Master's in Life Sciences

Tools

MS Office

Regulatory tools

Job description

Bavarian Nordic is seeking a Regulatory Affairs Manager to lead global regulatory activities across product registration and lifecycle management. You will work with cross-functional teams and health authorities to shape regulatory strategies and submissions, with occasional travel to partner sites.

The role requires a Master’s in Life Sciences and a minimum of five years in Regulatory Affairs within pharma drug development. Strong EU/US knowledge and English fluency are essential.