Pharmacovigilance and regulatory affairs manager BeNeLux

• Act as local single point of contact for global functions in Regulatory Affairs and Pharmacovigilance for the BeNeLux
• Act as the Local Safety Officer (LSO) for the Netherlands, Belgium and Luxembourg
• Act as primary contact for regulatory authorities and for external consultants, ensuring compliance of Product Information, approval of artworks for packaging materials and implementation of aRMM
• Responsible for creating and keep the local Regulatory affairs and Pharmacovigilance SOPs up to date
• Responsible for training of BeNeLux team in local Regulatory affairs and Pharmacovigilance SOPs
• Work closely together with Pharmacovigilance and regulatory affairs managers within the BNS cluster (BeNeLux Nordics and Switzerland) creating a network of knowledge and international cooperation and support
• Collaborate with commercial, medical and market access to realize cross-functional objectives

• Minimum 5-10 years of experience in regulatory affairs and pharmacovigilance within pharmaceutical company
• Knowledge of local pharmaceutical legislation for Regulatory in the BeNeLux region
• Knowledge of applicable laws and regulations to ensure full compliance
• Knowledge of Regulatory affairs and Pharmacovigilance activities (act as primary contact for regulatory authorities and for external consultants in the regions, ensuring compliance of Product Information, API, approval of artworks for packaging materials and implementation of aRMM)
• Proficiency in speaking, comprehending, reading and writing Dutch is required
• Proficiency in speaking, comprehending, reading and writing English is required
• Ability to think strategically & execute tactically

Proficiency in speaking, comprehending, reading and writing French is a plus

• Competitive salary and benefits package
• Opportunities for professional growth and development