Regulatory Affairs Officer "Labelling" M/F - 025

To ensure and coordinate the Linguistic Review (LR) for the Centralized products of one of our key clients, we are urgently looking for a Regulatory Affairs Officer “Labelling” based in France, Belgium or the Netherlands to join our internal teams.

About us

Group 10
Responsibilities

  • Coordinate and manage the Labelling team in charge of the Linguistic Review for the products of one of our key clients
  • Contribute to labelling related regulatory activities related to the Linguistic Review process for Centralized Procedure (CP) medicinal products (linguistic reviews for new MAA’s and post licensing changes)
  • Manage the relationship with the Translation partner and manage the translation tool to facilitate the review and coordination of Linguistic Review processes with internal and external stakeholders.
  • Provide ongoing support to the project teams to ensure project concerns are planned and accounted for.

Group 11
Education

  • At least a Bachelor’s Degree in Life Sciences. Ideally a Pharmacy Degree (PharmD).

Group 12
Experience

  • At least 3–4 years’ experience in Regulatory Labelling Operations in a Pharmaceutical Company or Service Provider

Group 13
Skills

Hard/Technical skills:

  • Good knowledge of regulatory labelling procedures.
  • Experience in Project Coordination/Management
  • Ideally experience in Line Management
  • Good IT skills/knowledge and the ability to learn appropriate softwares
  • Good understanding of Microsoft Suite

 

Soft skills:

  • Fluent English is mandatory, including excellent grammar skills (written and verbal fluency)
  • Fluent French or Dutch is also required
  • Excellent organizational and interpersonal skills
  • Excellent oral and written communication skills, including facing the client
  • Ability to work well within a team and autonomously
  • Ability to prioritize different workloads/multi-task
  • Ability to deliver on tight timelines
  • Personal responsibility for ensuring a high standard of work

Regulatory Affairs Officer "Labelling" M/F - 025