Regulatory Affairs Manager

Our client is the 19^th largest pharmaceutical company in Europe based in Diegem and is looking for a REGULATORY AFFAIRS MANAGER

You will be responsible for all regulatory activities within the organisation and report directly to the Country Manager

• Obtain & maintain marketing authorizations in Benelux.
• Put products on the market with a correct content of packaging components.
• Follow-up of pricing & reimbursement dossiers.
• Qualified Person for batch release.
• Responsible for administrative control of products from EU and management of quality complaints and related aspects (SOP and legislation).
• Back-up for Medical Director as contact person for Pharmacovigilance.
• Support to Medical and Marketing Departments.
• Coach the Regulatory Affairs Officer and Management Assistant.

• Master’s degree in pharmacy or equivalent.
• Several years of experience in regulatory affairs is mandatory.
• Knowledge of regulations for pharmaceutical products
• You have a good understanding of health economics, health outcomes and the ability to be articulated regarding these subjects.
• Ability to work in partnership with key functions (Commercial, Controlling, …)
• Accurate and efficient
• Flexible, dynamic, organized, team player
• Proficient in Dutch, French and English

• Competitive salaries and benefit packages
• Hospitalization and group insurance
• Home working
• Bonus plan
• Meal+Eco vouchers
• Mobility plan