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

ProductLife Group; Courbevoie; Sur place; EUR 35 000 - 55 000; Plein temps

Résumé du poste

An established industry player is seeking a dedicated Regulatory Affairs Officer / Linguistic Review Coordinator to join their dynamic team. This role involves coordinating the Linguistic Review for key medicinal products, managing relationships with translation partners, and ensuring regulatory compliance. The ideal candidate will have a strong background in regulatory labelling operations, excellent organizational skills, and the ability to work effectively both independently and within a team. If you're passionate about life sciences and looking to make a significant impact, this opportunity is perfect for you.

Qualifications

• 1-2 years of experience in Regulatory Labelling Operations.
• Experience in Project Coordination/Management is ideal.

Responsabilités

• Coordinate the Labelling team for Linguistic Review.
• Manage relationships with Translation partners.

Connaissances

Regulatory Labelling Procedures

Project Coordination

Microsoft Suite

Fluent English

Organizational Skills

Interpersonal Skills

Formation

Bachelor’s Degree in Life Sciences

Pharmacy Degree (PharmD)

Outils

Translation Tool

Project Management Software

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

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 oversee 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 addressed.

Group 11 Education

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

Group 12 Experience

• At least 1-2 years of experience in Regulatory Labelling Operations within 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.
• Proficient IT skills and ability to learn relevant software.
• Strong understanding of Microsoft Suite.
• Fluent in English, with excellent grammar skills (both written and verbal).

Skills (continued):

• Excellent organizational and interpersonal skills.
• Strong oral and written communication skills, including client-facing experience.
• Ability to work well within a team and independently.
• Effective prioritization of workloads and multitasking abilities.
• Ability to meet tight deadlines.
• Personal responsibility for maintaining high work standards.