Regulatory Affairs Specialist

As a successful Regulatory Affairs Specialist - Pharma - BeNeLux you will have the following responsibilities:

• Prepare, submit, maintain and record technical and regulatory documentation
• Ensure up to date EMEA document management system
• Collect information on products to create and update the product regulatory information
• Interpret regulatory requirements to ensure compliance of the products
• Provide support on compliance topics for the supply of raw materials to the pharmaceutical industry
• Participate in and support regulatory audits and inspections
• Monitor and assess changes in regulations, guidelines, and standards
• Support Change Control process
• Maintain communication and relation with regulatory stakeholders

As a successful Regulatory Affairs Specialist - Pharma - BeNeLux you will have the following requirements:

• Degree in life sciences or related fields
• +5 years of experience in regulatory documentation within the chemical or the pharmaceutical industry
• Deep knowledge of pharmaceutical industry requirements and regulations
• Strong expertise with European National Competent Authority requirements with distribution of ingredients and row material
• Autonomous profile but team player at the same time
• Able to work at a strategical and operational level at the same time
• Fluent in English and Dutch. French is a plus

As the successful Regulatory Affairs Specialist - Pharma - BeNeLux, you will have a Belgian permanent employment contract with:

• An attractive salary including an annual bonus based on performance and a complete package of extra legal benefits (Company Car, Net Allowances, Insurances, Extra Days Off...)
• The chance to join a dynamic and positive multicultural organization driven by results
• The possibility to be part of an international and expanding company with multiple growing opportunities.