Our client is the 19th 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