Senior Regulatory Specialist

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:

• MSc or PhD, or a BSc
• 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/or OTC products
• Experience interacting with Health Authorities in the Benelux cluster
• Full proficiency in Dutch and French is essential, as well as strong English communication skills
• RIP accreditation (Responsible for Information and Publicity) is advantageous

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

What our Client looks for in candidates

Our client's culture is built on core values that drives their success and fosters a supportive, innovative environment. They value Teamwork, where diverse perspectives and skills come together to enhance creativity and problem-solving. Innovation is at their core, as they continually seek better ways to achieve their goals and remain at the forefront of their industry. The client demonstrates their Commitment by exceeding expectations and building long-term relationships, while always striving for Excellence in everything they do. The client's foundation of Integrity ensures that honesty, ethical behaviour, and accountability guide their decisions. By proceeding with this job application, they understand that you share these values and look forward to reviewing your application and engaging with you further.

If you are ready to advance your career and have the skills and ambition for this position, please email your CV to Francesca Lidbetter at or contact (0).