- Prepare and maintain QRD-template leaflets in accordance with regulatory requirements.
- Ensure compliance with Belgian packaging requirements for clinical trial products.
- Demonstrate experience with type IA & IB variations and other regulatory submissions.
- Process administrative variations efficiently and accurately.
- Coordinate adjustments to packaging materials as needed to meet regulatory standards.
- Update and maintain their internal regulatory affairs database with relevant information and documentation.
- Collaborate with cross-functional teams to ensure regulatory compliance throughout the clinical trial lifecycle.
- Assist in the preparation of regulatory submissions and responses to regulatory authorities.
- Life Sciences background.
- Basic regulatory affairs knowledge and experience within the pharmaceutical or biotechnology industry.
- Fluent in English, French and Dutch.
- Excellent organizational skills and attention to detail.
- Ability to prioritize tasks and work efficiently in a fast-paced environment.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Proficiency in MS Office suite and regulatory affairs software tools.
- Ability to adapt to changing priorities and deadlines.
- Start Date: ASAP.
- Schedule: 0.5 FTE up to 0.8 FTE.
- LOA: 6 months.
- Travel: Fully remote.
- Location: Client is based in Belgium.
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Beschrijving
Our client, a pharmaceutical company based in Belgium is looking for a (Junior) Regulatory Affairs Specialist a to come on board and join their team.
The successful candidate will be responsible for managing regulatory affairs activities related to clinical trials, ensuring compliance with relevant regulations and standards. This position will involve handling administrative tasks, including but not limited to basic regulatory affairs activities such as QRD-template leaflets, Belgian packaging requirements, experience with type IA & IB variations, processing administrative variations, adjustments to packaging materials, and updating our internal database.
Tasks & Responsibilities:
Requirements:
Contract Information:
