Global RA Manager Consumer

publiziert 23 June 2022
GehaltNégociable
OrtLausanne
Jobtyp Temporärstellen
DisziplinLife Sciences
ReferenzBBBH542520_1655994151

Jobbeschreibung

For our partner in cosmetics, Kelly Life Sciences is looking for:

Global Regulatory Affairs Manager Consumer

You mission

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

Your responsibilities

  • 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 track RA activities databases
  • Supports the development of labelling and artworks for medical devices and cosmetics
  • Ensure right processes and structures are in place for Medical devices

Your 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

You contact at Kelly: Anaïs MIESZCZAK