Regulatory Affairs Officer
il y a 1 mois
Regulatory Affairs Officer / Linguistic Review Coordinator 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 / Linguistic Review Coordinator based in the EU 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 1-2 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 SuiteSoft skills:
Fluent English is mandatory, including excellent grammar skills (written and verbal fluency) 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-
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