Senior Regulatory Affairs Specialist
: Job Details :


Senior Regulatory Affairs Specialist

Haybury Limited

Job Location : Brussels, UK

Posted on : 27/01/2025 - Valid Till : 27/01/2025

Job Description :

Overview

A prestigious and well established pharmaceutical company, known for its significant growth and operational excellence, is seeking a driven and detail-oriented Regulatory Affairs Specialist to oversee regulatory activities in the Benelux region.

This dynamic role combines strategic and operational responsibilities. With a lean reporting structure and high autonomy, you will have the opportunity to lead projects from inception to completion, implementing regulatory strategies and liaising directly with Health Authorities.

Responsibilities:

  • Manage regulatory submissions, lifecycle maintenance activities, and ensure compliance with local regulations
  • Prepare, review, and submit marketing authorisations, variations, renewals, and withdrawals
  • Develop and execute regulatory plans while staying updated on regulatory developments
  • Build strong relationships with key stakeholders, clients, and Health Authorities through regular communication and collaboration
  • Lead and manage multiple regulatory projects, ensuring timely and solutions-focused outcomes

Experience & Qualifications:

  • A degree in Pharmacy, Medicine, Surgery, Obstetrics, or a Master’s/PhD in Pharmaceutical Sciences or a related scientific discipline, as required to meet the qualifications for a Responsible Person (RP) under Good Distribution Practice (GDP) regulations
  • A few years of proven experience in Regulatory Affairs within the pharmaceutical industry, with a strong understanding of pharmaceutical quality systems, regulatory frameworks, and compliance standards
  • Expertise in managing prescription medicines and engaging with Health Authorities in Belgium and the Netherlands
  • Full proficiency in both Dutch and French is essential, as well as strong English communication skills

In Return, you will receive:

  • A highly competitive salary and bonus package
  • Comprehensive benefits, including a hybrid working model
  • The chance to work autonomously and make a lasting impact within a forward-thinking organisation

If you are ready to advance your career and have the skills and ambition for this position, please email your CV to Vicki Taggart.

Apply Now!

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