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 have embarked upon a truly transformative journey towards becoming one of the largest pure play vaccine companies by excelling in R&D innovation, manufacturing and commercialization, and are looking for more talent to help drive the change. Come on board our journey and let’s change more lives, together.

About the job:

• Define the worldwide regulatory affairs strategy in collaboration with the

team members and ensure consistency with the Company strategic goals

• Responsible to ensure timely decision-making, risk mitigation and
• prioritization to meet goals and drive progress
• Represent RA at cross functions meetings, driving cross functional alignment towards the regulatory strategy
• Responsible for maintenance of regulatory life-cycle management for

worldwide licensed products (e.g. preparation, coordination and submission in due-time of variations/supplements/annual reports and coordination of Health Authority responses)

• Responsible for the review and approval of artworks in compliance

with the current regulatory guidelines and law

• Support of local representatives for questions raised by the local Health

Authority for shortage and complaints

• Leadership of 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 analyzing 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 work force. We offer a fast-paced work environment and an opportunity to develop both your personal and academic competencies. We empower our employees to build rewarding careers. Job satisfaction and personal development has a high priority.
Caught your interest?
If you are interested in the position, we look forward to receiving your application via our recruitment system.
We are interviewing on an ongoing basis.
Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values – our Bavarian Nordic DNA, as we like to call it – are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! 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.
www.bavarian-nordic.co

Please refer the Job description for details