Regulatory Affairs Manager (f/m/d)

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

Regulatory Affairs Manager (f/m/d)

Bavarian Nordic Berna GmbH Vacant since : 06.10.2026 Number of jobs : 1 3174 Thörishaus (BE) 100% Immediately Permanent

Join our Regulatory Affairs team and play a pivotal role in bringing innovative biologic products to patients worldwide. As Regulatory Affairs Manager located in Martinsried (Munich), Törishaus (Bern) or Kvistgaard, you will lead global regulatory activities across product registration and lifecycle management, working closely with cross-functional teams and health authorities.

This is an exciting opportunity for an experienced regulatory professional to shape regulatory strategies, drive successful submissions, and contribute to the delivery of high-quality healthcare solutions. Occasional travel should be expected.

Your 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 and interpret evolving regulatory requirements, guidelines and legislation, communicating relevant updates to stakeholders and supporting organizational compliance
• Contribute to regulatory operational excellence through process improvements, and the development and maintenance of Regulatory Affairs SOPs and work instructions

About you

• Master’s degree in Life Sciences (e.g., Biology, Molecular Biology, Biochemistry, Pharmacy) 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 experience with major regulatory frameworks such as EU and/or US
• Ideally experience supporting the registration and lifecycle management of biologic products
• Solid knowledge of pharmaceutical regulations and regulatory intelligence, with the ability to interpret evolving requirements and provide sound regulatory guidance
• Excellent communication and stakeholder management skills, with the ability to collaborate effectively across cross-functional and international teams; fluent in written and spoken English
• Highly detail-oriented with strong analytical skills, including the ability to evaluate scientific data and translate complex information into high-quality regulatory documentation; proficient in standard computer applications and digital systems

What We Offer

• A high-ownership role with direct influence on operational performance, giving you clear responsibility and visible impact
• Collaboration with international suppliers and cross-functional teams, working in a dynamic and global environment
• Professional development and growth opportunities within a forward-thinking and innovation-driven organization
• A supportive team culture and a flexible working environment that values trust, autonomy and work-life balance

Are you ready to join us in our mission?

Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America.

Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

For more information, visit www.bavarian-nordic.com

• Work location 3174 Thörishaus (BE)
• Workload 100%
• Employment start Immediately
• Employment duration Permanent

• Qualification skilled
• Work experience More than 3 years
• Education Master’s degree from a university or equivalent

• English Orally : Very good knowledge Written : Very good knowledge

• By online Online form