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Regulatory Affairs Officer / Linguistic Review Coordinator M/F

We are seeking a highly skilled Regulatory Affairs Officer / Linguistic Review Coordinator to join our team at ProductLife Group. As a key member of our internal teams, you will be responsible for ensuring and coordinating the Linguistic Review for Centralized products of one of our key clients.

About ProductLife Group

ProductLife Group is a leading company in the pharmaceutical industry, dedicated to providing innovative solutions for our clients. Our team is passionate about delivering high-quality services and products that meet the highest standards of regulatory compliance.

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.

Personal Qualities

  • 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.