You will shape and lead the European regulatory strategy.
On behalf of an international pharmaceutical / medtech group with a strong European presence in Belgium and a portfolio of marketed products and a growing pipeline, we are recruiting a Director Regulatory Affairs to drive regulatory strategy across Europe and selected international markets.
The context
Regulatory Affairs is a key strategic growth lever for the group.
As the organisation continues to expand its pipeline and geographic footprint, the existing Regulatory Affairs function must be further structured and strengthened to support long-term business objectives.
Your role
* Define and lead the European and international regulatory strategy
* Structure, develop and manage the Regulatory Affairs team
* Oversee registration, variation and lifecycle management activities
* Act as the primary interface with European health authorities
* Anticipate regulatory changes and assess their business impact
* Support senior management with strategic regulatory guidance
Your background
* Advanced degree in Pharmacy, Life Sciences or Health Law
* Minimum 12 years' experience in Pharmaceutical Regulatory Affairs
* Proven leadership experience managing teams and multi-country scopes
* Strong expertise in European procedures (Centralised, MRP, DCP)
* Strategic mindset, leadership presence and influencing capability
* Fluent English and French; Dutch is a strong asset
* Nice to have: experience in Medical Devices and established relationships with European authorities
Offer
* Executive-level compensation package, aligned with the Belgian market
* High-visibility, strategic role with direct impact on business decisions
* Key leadership position within a growing international organisation
This search is conducted confidentially by Recrutis, a Life Sciences executive search firm.
Exploratory and confidential discussions are welcome.