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Regulatory Affairs Specialist
il y a 2 semaines
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Regulatory Affairs Specialist
Il y a 2 mois
The Regulatory Affairs Specialist will be responsible for the meticulous preparation of submissions related to license modifications, notifications, and renewals, adhering to stringent deadlines.
Key Responsibilities- Monitor and establish timelines for the approval processes of license variations, notifications, and renewals.
- Prepare essential documents including the Summary of Product Characteristics, Patient Information Leaflets, and labeling in compliance with the Quality Review Documents (QRD) format.
- Provide continuous regulatory support to the Regulatory Affairs Manager(s) and project teams, ensuring that regulatory considerations are integrated into project planning and that necessary data is produced to fulfill project goals.
- Stay informed about current national and international regulations and guidelines.
A scientific background is essential, with a preference for candidates holding a master’s degree in pharmaceutics, healthcare, life sciences, or related disciplines. Candidates should possess approximately 2+ years of experience in a comparable role, ideally within an international context.
SkillsFluency in English, both written and spoken, is required, while proficiency in Dutch is considered an advantage.
