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Regulatory Affairs Officer – Diegem

Introduction

For our customer, a worldwide, innovative pharmaceutical leading company, we are looking for a Regulatory Affairs Officer.

Function

– Regulatory activities

o Preparations activities for all submissions of the entire Clients NL portfolio (life cycle management and launches), which includes for example:

 The preparation and finalizing of the NL labeling.

 The preparation and finalization of any local driven documentation according to the law/legislation.

 Finalization of the submission package.

 Preparation and finalization of the risk minimalization materials (aRMM’s).

 Coordination of all activities with Paraxel to ensure submission by submission vendor.

 Ensuring on time submission to maintain the submission KPI.

o Implementation of health agency approvals, which includes:

 Local database update with the approved NL labeling which is used by the Business and informing the Business of any health authority approval.

 Updating/creation of the VPI for promotional activities.

 Implementation of Agency approved aRMM’s.

 Global database update (like SHARE, RWS-LOL, Veeva Vault, and cross references with SHARE).

– Implementation of health agency approvals

– Industrial implementation

 Ensuring Regulatory compliance in our packaging and according to the law/legislation and Sanofi’s policies to ensure completion of the end to end process.

 Coordination of minimalization of destruction costs by manufacturing sites.

– Project support for example but not limited to:

 Prunings/ discontinuations.

 CCSI Authoring Project.

 Also any local driven business projects like, for example implementation of 2D code on primary label.

– Database management

Requirements

-HBO/Master Degree, preferably in Medical/ Pharmaceutical or Biochemistry.

-Preferably 1-3 years in Regulatory Affairs.

Information

Mieke Gysens +32 497 59 44 26

Application

Mieke Gysens +32 497 59 44 26

Mieke.gysens@medipartner.be