Senior Regulatory Affairs Manager Benelux (Pharma/Medical Device)

Join a Major company in the Dermatology and Skin Care space as a Regulatory Affairs Manager, and lead regulatory strategy and execution across the Benelux region.

Role:

As the Regulatory Affairs Manager, you will oversee regulatory activities across multiple product classes including medicinal products, medical devices, and cosmetics, ensuring compliance with regional health authorities while supporting successful product registrations and lifecycle management.

This is a senior individual contributor role with significant regulatory ownership and strategic influence across the business.

Key Responsibilities:

Strategic Leadership & Compliance

• Lead all Regulatory Affairs activities for medicinal products, medical devices, and cosmetics across the Benelux (Netherlands, Belgium, Luxembourg), ensuring alignment with business objectives.

• Develop and execute regulatory strategies to accelerate product approvals and maintain compliance throughout the product lifecycle.

• Serve as the primary company contact for Health Authority interactions, managing negotiations and regulatory submissions.

• Monitor regulatory and legislative changes, ensuring prompt compliance and strategic adaptation for business impact.

• Represent the company in key industry associations and external committees.

Operational Management

• Oversee product registrations, lifecycle management (variations, renewals, post-approval commitments), and ensure timely approvals of permits and licenses.

• Review and approve promotional/non-promotional materials, packaging artworks, and other regulated documents according to SOPs.

• Manage regulatory databases, in-house files, and ensure up-to-date documentation.

• Plan and oversee the Regulatory Affairs budget and resource allocation.

Cross-functional Collaboration & Support

• Advise on regulatory issues regarding commercial activities, service provider contracts, distribution agreements, trademarks, and related legal matters.

• Liaise with Corporate Regulatory Affairs to align local strategies with global policies and guidelines.

Information and Publicity

• Ensure compliance of SmPC, PIL, advertising materials, and “Declaration of Conformity” for variations.

• Oversee the training and approval process for medical representatives.

• Establish and maintain SOPs for advertising, promotional activities, and the provision of information to healthcare professionals and patients.

• Ensure compliance with regulations on samples and incentives in coordination with Compliance and Quality teams.

Qualifications and Experience

• University degree in a scientific discipline (PharmD preferred; MD or Chemistry also considered).

• At least 7 years' Regulatory Affairs experience within the pharmaceutical sector, covering both medicinal products and medical devices. Cosmetic product experience is a plus.

• Strong knowledge of the Benelux pharmaceutical industry, with emphasis on product launch preparation and life-cycle management.

• Fluent in English and Dutch (French is an advantage).

• Solid business acumen, especially concerning upcoming product launches.

• Familiarity with Quality Assurance (GxP standards).

• Effective oral communication and public speaking (Dutch, English; French is a plus).

• In-depth understanding of healthcare systems, pharmacoeconomics, and pricing regulations.

• Strong grasp of regulatory compliance requirements.

• Demonstrated leadership, strategic thinking, and experience working in matrix organizations and international teams.

• Strong project and time management capabilities.

• Negotiation skills.

• Information management.

• Willingness to travel.