Senior Regulatory Specialist

il y a 2 semaines


Bruxelles, Région de Bruxelles, Belgique Haybury Temps plein

Haybury Brussels, Brussels Region, Belgium

Senior Regulatory Specialist

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
  • RIP (Responsible for Information and Publicity) is preferred
  • Several 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/non-prescription/OTC/generic medications
  • Experience engaging with Health Authorities in the Benelux cluster
  • Full proficiency in 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 Heather Cain on heather.cain@hayburysearch.com or contact +44 (0)1273 059 648.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance, Project Management, and Science

Industries

Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing

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