To support the recruitment process of one of our clients located in the region of Zaventem, we are actively looking for a Regulatory Affairs Officer.
- Do you have a Pharmacist Degree?
- Do you have at least 1 to 2 years of experience in the Regulatory Affairs?
- Do you have a good knowledge of languages (NL/FR/ENG)?
Then this could be the right opportunity to lift your career to the next step!
As a Regulatory Affairs (RA) Professional you play a crucial role in the lifecycle of a medicine, you guide the drug through all phases of development.
•You keep track of ever-changing regulation in all regions where the product is distributed.
•You advise on legal and scientific restraints and requirements.
•You collect and evaluate scientific data, generated by your R&D colleagues and relevant stakeholders.
•You oversee all the deadlines and keep track that the submission milestones are reached.
•You maintain the system processes, identify process optimization opportunities and assist in the resolution of technical issues for the publishing dossiers.
•You interact with local authorities and carry out all negotiations necessary to obtain and maintain marketing authorization for the product.
•You prepare, handle, distribute and file submissions to the Competent Authorities and Central/ Local Ethic committees via different National and European procedures
•You provide strategic and operational regulatory advice and support in the management of all submission activities
•You contribute to the life-cycle maintenance of existing registrations (MRP, DCP, National) by managing the variation dossiers and renewals
•You provide regulatory responses to health authority questions
•You are involved in different artwork activities (translations of leaflets and labellings, review of artworks and change requests, review and approval of packaging materials,...)
•You keep the registration databases up-to-date and maintain a close eye on the RA product launches and deadlines
•Internal departments: Market Access, Quality Assurance, Logistics, Marketing, ...
•You establish and maintain sound working relationships with external partners and Health Authority Institutions
- You possess a (industrial) Pharmacist degree
- You have a minimum of 1 to 2 years’ experience in the pharmaceutical industry, more specific in the Regulatory Affairs.
- You have a sound knowledge of EU regulatory procedures and development of medicinal products in general.
- You speak fluently Dutch, English and French
- You have good organizational skills, proven ability to multi-task and an excellent eye for details
- You take leadership of your projects and can work independently within set deadlines
- You have a scientific mindset and excellent analytical skills.
Talent Acquisition Associate
t +3215 21 11 04