Senior Regulatory Affairs Specialist, DE

Senior Regulatory Affairs Specialist, Munich, Germany


KLIFO is looking for a Senior Regulatory Affairs Specialist for our Munich Office 

The position

KLIFO is expanding its service offering in Germany by introducing a similar end-to-end drug development consultancy to what the company has in Denmark, including a Regulatory Affairs Solutions department. 

The Senior Regulatory Affairs Specialist will be instrumental in building up our Munich-based regulatory affairs team and supporting the establishment of new regulatory affairs business in Germany and the DACH region. In addition, the position requires a hands-on approach to service existing and new clients. The successful candidate will report to the Senior Director Strategic Planning & BD in Munich and work in close collaboration with the Vice President, Regulatory Affairs Services from company headquarters in Denmark. 

Functions as Regulatory Affairs team Leader 

  • Project management 
  • Strategic advice 
  • Liaison with competent authorities 
  • General regulatory affairs work 
  • Management of regulatory procedures 
  • Preparation of submissions to Agencies 
  • Project management and cross-functional collaboration within KLIFO 

Qualifications and requirements 

  • MSC from the life sciences field or Regulatory Affairs specific diploma/master 
  • A minimum of 10 years regulatory experience 
  • Profound knowledge of regulatory guidelines, terminology and processes 
  • Experience in liaison with Medicines Agencies i.e. PEI, BfArM and EMA/FDA 
  • Drug development experience 
  • Network of regulatory experts in DACH 
  • Good leadership skills 
  • Collaborative mind-set 
  • Personal fit with KLIFO’s culture and way of working 
  • Extrovert service oriented mindset, preferably with experience from pharma and biotech 
  • Excellent communication skills, fluent in German and English (written and verbal) 
  • Willingness to work from client sites, when required 
  • Ability to travel for work (in Europe, up to 25%) 

We offer

  • Work within different therapeutic areas and with tasks of varying complexity 
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia) 
  • Join a team of experienced colleagues where you use and elaborate your skills and competences 
  • Work in a European-based company with global reach 
  • Work in an interactive, flexible and positive working environment with a high-level of transparency and influence 
  • Flexibility to work partially home-based 

Location

This position is located at our office in Munich, Germany. 

Contact

For more information, please contact Christine Tiesler, at moc.ofilk@relseit.enitsirhc.

Applications should be sent to 

moc.ofilk@boj marked ‘Senior Regulatory Affairs Specialist, Munich’. 

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR). 

Deadline: 31 March 2020 

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For more information about KLIFO, visit www.klifo.com.