Specialist Regulatory Affairs – Benelux

The role will consist to work for the local implementation of global regulatory strategies, and obtaining, maintaining marketing authorizations for product(s) and communication of local regulatory requirements. Manage regulatory activities relating to specific portfolio of products/projects in the Benelux.

• Lead or represent Regulatory Affairs in project teams

• Initiate and develop complex regulatory project plans
• Identify & prioritize key areas of regulatory risk
• Provide regulatory advice to project teams
• Monitor applicable regulatory requirements
• Respond to complex questions from regulatory authorities within strict timelines
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
• Maintain and update existing regulatory authorizations

• Create and maintain regulatory files in a format consistent with requirements
• Prepare, review, and approve labeling
• Manage regulatory activities relating to specific portfolio of products/projects
• Prepare procedures to reflect specific local requirements
• Review AdProm materials for compliance with local regulations
• Contribute to registration in export countries (CPPs, legalizations, etc.)
• Perform QC check (translation and transcription) of Benelux Pharmacovigilance cases
• Provide guidance and coaching for areas of responsibility to lower level team members

Qualifications

• Fluency in French, Dutch and English is a must
• Knowledge of regulations
• Scientific knowledge
• Project management skills
• Manage multiple projects and deadlines
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Strong negotiation skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Ability to work effectively in multinational/multicultural environment
• Ability to identify compliance risks and escalate when necessary

Education and/or Experience

Bachelor’s degree or country equivalent in a relevant scientific discipline.

Minimum of 5-year regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO or similar organization.