Posted to MedZilla on 3/26/2017


ProClinical

Germany, Regulatory Affairs Specialist RA_HB_11301-MZ


 
 

Our client, a growing healthcare company, is looking for a Regulatory Affairs Specialist to join their team in Germany. The company specialises in developing supplements for athletes.

Job Responsibilities:

  • Creation of (e-CTD) and submission of collated packages to BfArM: CESP-Portal and XEVMPD
  • Maintenance of variations and renewals
  • Coordination and timely response to complaints
  • Maintenance of internal and health authorities databases, electronic archiving, submission checking
  • Cooperation with lauch & portfoliomanagement, Artowrk as well as drug safety department

Job Requirements:

  • Several years of experience in BfArM Submissions, including updating of dossiers according to §10-11 AMG and experience in the maintenance of XEVMPD
  • Entrepreneurial spirit and high degree of reliability
  • Able to perform under pressure with previous project management experience

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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