Senior Manager Regulatory Affairs

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 regulato