Global Regulatory Affairs Lead for Biologics & Lifecycle

Bavarian Nordic Berna GmbH; Köniz; On-site; CHF 120,000 - 180,000; Full time

Job summary

Bavarian Nordic Berna GmbH is seeking a Regulatory Affairs Manager to lead global regulatory activities and lifecycle management from multiple locations including Bern. The role collaborates with cross-functional teams to drive regulatory strategies and high-quality submissions in a dynamic, international environment.

Responsibilities include coordinating submissions, maintaining compliance with EU/US requirements, and supporting post-approval activities.

Qualifications

• Master’s degree in Life Sciences or a related scientific discipline.
• Minimum of 5 years of Regulatory Affairs experience within pharmaceutical drug development, ideally in a global environment.
• Strong understanding of regulatory submission and approval processes, including EU and/or US frameworks.
• Ideally experience supporting registration and lifecycle management of biologic products.
• Fluent in written and spoken English.
• Highly detail-oriented with strong analytical skills and ability to translate data into regulatory documents.

Responsibilities

• Lead regulatory activities for assigned lifecycle management projects, including global product expansions.
• Develop and execute regulatory strategies for post-approval activities, ensuring alignment with business objectives and global regulatory requirements.
• Prepare, coordinate and submit high-quality regulatory documentation, including briefing packages, variations, supplements and marketing authorization submissions.
• Act as the Regulatory Affairs lead within cross-functional project teams, providing strategic guidance throughout post-authorization processes.
• Coordinate responses to health authority questions and regulatory review procedures, ensuring timely and compliant interactions with regulatory agencies worldwide.
• Monitor evolving regulatory requirements and communicate updates to stakeholders; support organizational compliance.
• Contribute to regulatory operational excellence through process improvements and SOPs.

Skills

English (spoken & written)

Stakeholder management

Regulatory interpretation

Education

Master’s degree in Life Sciences or related field

Job description

Bavarian Nordic Berna GmbH is seeking a Regulatory Affairs Manager to lead global regulatory activities and lifecycle management from multiple locations including Bern. The role collaborates with cross-functional teams to drive regulatory strategies and high-quality submissions in a dynamic, international environment.

Responsibilities include coordinating submissions, maintaining compliance with EU/US requirements, and supporting post-approval activities.