Posted to MedZilla on 3/26/2017


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


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.