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.
- 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
- 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
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.