Head of Regulatory Affairs

Employer
Medella Life
Location
Germany (DE)
Salary
Up to €90000, dependent on experience
Closing date
16 Oct 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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Job responsibilities 

  • Develop in-house regulatory expertise, including the establishment and growth of a Regulatory department 
  • Development and execution of regional and global regulatory strategies with country-specific requirements 
  • Selection and oversight of external vendors including the coordination of vendor/consultant activities to ensure compliance with all internal SOPs and national/international requirements
  • Review and approval of new or amended packaging components in line with the products’ licenses for the products marketed locally
  • Assisting in the review and approval of promotional and non-promotional materials  
  • Contribution to cross-functional and affiliate leadership matters
  • Support pricing activities related to both maintaining market access and achieving new reimbursed access for company products in Germany 

 

Skills required 

 

  •  6 + years’ experience in Regulatory Affairs – (Biotech, Pharmaceutical or CRO background all considered)
  • Experience in developing and implementing regulatory strategy as well as leading complex negotiations with Regulatory Authorities
  • Leadership experience including internal/external regulatory teams in matrix organizations 
  • Proven experience in working with BfArM (Experience with EMA & FDA advantageous) 
  • Proven leadership of regulatory activities for the commercial launch of new products
  • Regulatory experience in due diligence both of early opportunities and products in late development
  • Fluency in German and English

Company Profile

As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything we do.  

​No matter how hard, at Medella Life we live by our values. We may be new, but we are here to earn our stripes. Our founding team has more than twenty-five years experience in the field. Our mission is to be your first call when looking for A-list talent. What matters to us is being the best, not being the biggest. That's why we value quality over quantity. It is our belief that science can save the world. Which is why a Medella Life is a good life.

Contact Us
  • 10 York Road
  • London
  • SE1 7ND
  • United Kingdom
  • +44 20 4511 0354
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