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Regulatory Affairs Specialist
hace 2 meses
We are seeking a highly skilled Regulatory Affairs Associate to join our team at Meet. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with regulatory requirements and guidelines.
Responsibilities:- Assist in the preparation and submission of regulatory documents to regulatory agencies
- Prepare submissions of license variations, notifications, and renewals to strict deadlines
- Monitor and set timelines for license variations, notifications, and renewal approvals
- Ensure compliance with regulatory requirements and guidelines
- Monitor and update regulatory documentation as necessary
- Participate in meetings with regulatory agencies and manufacturers as needed
- Advise manufacturers on regulatory requirements
- Document and track regulatory submissions and regulatory authority approval
- Review, proofread, and approve artwork of packaging materials to ensure compliance with regulatory requirements
- Prepare Summary of Product Characteristics, Patient Information Leaflets, and labeling according to the Quality Review Documents (QRD) format
- Scientific background with a master's degree in pharmaceutics, health care, life sciences, or related fields preferred
- 2+ years of experience in a similar role, preferably in an international environment
- Excellent planning and time management skills
- Good knowledge of relevant European guidelines, applicable legislation, and regulations
- Fluent communication skills in English (written and oral); Dutch is an asset
- A dynamic and collaborative work environment
- Opportunities for professional growth and development
- A competitive salary and benefits package