Senior Regulatory Affairs Specialist - Haybury Limited : Job Details

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.