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Regulatory Affairs Specialist New
Il y a 3 mois
Location:
Diegem, Belgium
- Contact:
- Job type:
- Contact phone:
- Industry:
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.
Tasks & Responsibilities:
- Prepare and maintain QRDtemplate 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 crossfunctional teams to ensure regulatory compliance throughout the clinical trial lifecycle.
- Assist in the preparation of regulatory submissions and responses to regulatory authorities.
Requirements:
- 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 fastpaced environment.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with crossfunctional teams.
- Proficiency in MS Office suite and regulatory affairs software tools.
- Ability to adapt to changing priorities and deadlines.
Contract Information:
- Start Date: ASAP.
- Schedule: 0.5 FTE up to 0.8 FTE.
- LOA: 6 months.
- Travel: Fully remote.
- Location: Client is based in Belgium.
