- 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
- 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
- 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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Regulatory Affairs Officer - Courbevoie, France - ProductLife Group
Description
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 ResponsibilitiesHard/Technical skills:
Soft skills:
