Senior Manager Regulatory Affairs

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Senior Manager Regulatory Affairs (m/f/d)

• Located in Germany, Switzerland or Denmark

Would you like to join a dedicated Global Regulators Affairs Team to ensure development and marketing authorisation of key vaccines within infectious diseases?

Join our transformative journey

At Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system. We are a global leader in smallpox vaccines and our commercial product portfolio contains market‑leading vaccines against rabies and tick‑borne encephalitis as well as an Ebola vaccine licensed to Janssen. We are embarking on a truly transformative journey towards becoming one of the largest pure‑play vaccine companies by excelling in R&D innovation, manufacturing and commercialisation, and are looking for more talent to help drive the change. Come aboard and let’s change more lives, together.

About the job

• Define the worldwide regulatory affairs strategy in collaboration with team members and ensure consistency with the company’s strategic goals.
• Responsible to ensure timely decision‑making, risk mitigation and prioritisation to meet goals and drive progress.
• Represent RA at cross‑functional meetings, driving cross‑functional alignment towards the regulatory strategy.
• Maintain the regulatory life‑cycle management for worldwide licensed products (e.g. preparation, coordination and submission of variations/supplements/annual reports and coordination of Health Authority responses).
• Review and approve artworks in compliance with current regulatory guidelines and law.
• Support local representatives for questions raised by the local Health Authority regarding shortages and complaints.
• Lead allocated health authority meetings.
• Liaise and coach functional areas and team members (e.g. Medical Strategy/Medical Affairs, Nonclinical, CMC, Regulatory, Project Management) to ensure documents are compliant with internationally accepted submission guidelines (e.g. ICH).

About You

• At least 7 years of experience in regulatory activities.
• Experience in product development and/or post‑licensure with biologics.
• Experience in leading cross‑functional interactions related to regulatory matters.
• Fluent in English with excellent written and verbal communication skills.
• A team player with the ability to work well with other functional teams to achieve regulatory objectives and to work effectively within global project teams.
• Detail‑oriented in analysing and interpreting scientific data for integration into regulatory documents.

We offer

A chance to work in an international company with unique technology and a dedicated workforce. We offer a fast‑paced work environment and opportunities to develop both your personal and academic competencies. We empower employees to build rewarding careers. Job satisfaction and personal development have a high priority.

Caught your interest?

If you are interested in the position, we look forward to receiving your application via our recruitment system. Just click the Apply‑Button on the right side of the page and you will be redirected to our application form. We are interviewing on an ongoing basis.

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.