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

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

Résumé du poste

An established industry player is seeking a Regulatory Affairs Officer / Linguistic Review Coordinator to join their dynamic team in Paris. This role involves coordinating the Labelling team and managing the Linguistic Review processes for key clients. The ideal candidate will have a strong background in regulatory labelling operations and excellent communication skills. You will be responsible for managing relationships with translation partners and ensuring the successful execution of projects. If you are passionate about regulatory affairs and thrive in a collaborative environment, this is the perfect opportunity to make a significant impact in the pharmaceutical industry.

Qualifications

• 1-2 years’ experience in Regulatory Labelling Operations is required.
• Good knowledge of regulatory labelling procedures is essential.

Responsabilités

• Coordinate the Labelling team for the Linguistic Review process.
• Manage relationships with Translation partners and coordinate reviews.

Connaissances

Regulatory labelling procedures

Project Coordination

Line Management

IT skills

Microsoft Suite

Fluent English

Organizational skills

Interpersonal skills

Communication skills

Multi-tasking

Formation

Bachelor’s Degree in Life Sciences

Pharmacy Degree (PharmD)

Outils

Translation tool

Description du poste

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

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.

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 software.
• 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.