Global Regulatory Affairs Manager Consumer

Offre de CDD


Description

Your mission : Under the supervision of the Team Head, the RA Manager contributes to the development, preparation of dossiers and global coordination of medicals devices and cosmetics for regulatory aspects for worldwide registration. The role also includes knowledge on combination products. CDD 18 months.

Your responsabilities :
– Setting up the regulatory strategy for projects under development
– Cooperates with affiliates (through hubs) in order to perform a feasibility analysis of projects roll out WW based on regional/national regulations.
– Coordinates the preparation and participate to meetings with Health Authorities /Notified Bodies if necessary
– Communication of project relevant RA information to Project Team and Department Heads
– Represents RA for medical devices or cosmetics in global & cross functional meetings
– Ensure compliance of claims
– Provides regulatory support to ensure the content of dossier/PIF/TF is compliant with relevant regulations and is sufficient for submission / notification
– Updates PIF periodically or upon specific request
– Ensures regulatory support for new product launch
– Maintains and tracks RA activities databases
– Supports the development of labelling and artworks for medical devices and cosmetics
– Ensures right processes and structures are in place for medical devices

Profile :
PhD ( in Sciences, Medicine or Pharmacy), Master or any equivalent advanced scientific degree in a related technical field
Several years (>5) of prior experience in global regulatory affairs in cosmetics
Experience in medical devices is an asset
Fluent in English, French is an asset
Strong interpersonal, communication and organizational skills