Senior Regulatory Specialist
il y a 2 semaines
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
- 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.
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