Regulatory Affairs Specialist

il y a 2 semaines

Courbevoie, Île-de-France ProductLife Group Temps plein
Regulatory Affairs Officer / Linguistic Review Coordinator

ProductLife Group

We are seeking a highly skilled Regulatory Affairs Officer / Linguistic Review Coordinator to join our internal teams in the EU. The successful candidate will be responsible for ensuring and coordinating the Linguistic Review for the Centralized products of one of our key clients.

About Us

ProductLife Group is a leading provider of regulatory affairs services to the pharmaceutical industry. Our team of experts is dedicated to helping clients navigate the complex regulatory landscape and bring their products to market efficiently.

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.
Requirements
  • At least a Bachelor's Degree in Life Sciences. Ideally a Pharmacy Degree (PharmD).
  • At least 1-2 years' experience in Regulatory Labelling Operations in a Pharmaceutical Company or Service Provider.
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.
Soft 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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