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Emploi: Regulatory Affairs Expert:Mielabelo SPRL

Job description:


Mielabelo SPRL

Regulatory Affairs Expert

   » Brabant Wallon
   » Contrat fixe à durée indéterminée
   » Plein temps
   »

Challenge |

Innovating actor in Business Services sector, Mielabelo is an expanding consulting firm that aims to optimize its clients? performance by focusing on Continuous Improvement, Information System Management and Sales Performance. In order to support its team and enhance its development, Mielabelo is urgently looking for a new colleague. 

Talent |

   » Responsible of planification, coordination and review of regulatory submissions.
   » Identify and gather mandatory documents for regulatory submissions.
   » Review of submissions.
   » Create and update submission files.
   » Marketing authorizations management.
   » Serious Adverse Events (SAE) management.
   » Hands on DSUR (Development Safety Update Report) and PSUR (Periodic Safety Update Report).

Casting |

   » Master in biology, biotechnology, biochemistry, pharmacy.
   » FR/EN
   » practice in pharmacovigilance, drug safety, clinical trials management or regulatory affairs.
   » expertises of MedDRA, WHO Drug Dictionary or CTCAE (Common Terminology Criteria for Adverse Events).
   » expertises of cGMP, GCP, CFR 21, Eudralex, pharmacopeia and ICH.

Package |

We offer you an attractive income and fringe benefits including a company car, mobile phone and laptop, health insurance, representation costs, meal vouchers and financial bonuses located on Mielabelo?s performance.

Are you willing to provide innovative advice?

Don?t hesitate to contact us at generation@mielabelo.com!

Lieu

Mielabelo SPRL
1300 Brabant Wallon, Belgique

appliquer

Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Ander
Company Type Employer
Post Date: 09/15/2018 / Viewed 7 times
Contact Information
Company: Mielabelo SPRL
Contact Email: generation@mielabelo.com


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