Regulatory Affairs Officer / Linguistic Review Coordinator M/F - 025

Groupe ProductLife; Paris; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading company in regulatory affairs is urgently seeking a Regulatory Affairs Officer / Linguistic Review Coordinator in Paris. You will coordinate the Linguistic Review for centralized products, manage the labelling team, and ensure compliance with regulatory standards. Ideal candidates will hold a degree in Life Sciences, ideally Pharmacy, with 1-2 years of relevant experience and strong communication skills.

Qualifications

• Bachelor's degree in Life Sciences or ideally Pharmacy.
• 1-2 years' experience in Regulatory Labelling Operations.
• Fluency in English with excellent grammar.

Responsabilités

• Coordinate and manage the Labelling team for Linguistic Review.
• Contribute to labelling regulatory activities for Centralized Medicinal products.
• Manage relationships with Translation partners.

Connaissances

Regulatory labelling procedures

Project Coordination

Microsoft Suite

Fluent English

Organizational skills

Communication skills

Formation

Bachelor’s Degree in Life Sciences

Pharmacy Degree (PharmD)

Description du poste

Regulatory Affairs Officer / Linguistic Review Coordinator M/F - 025

Europe

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Permanent contract

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.

• 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.

Education

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

Experience

• At least 1-2 years’ experience in Regulatory Labelling Operations in a Pharmaceutical Company or Service Provider

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
• 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