Regulatory Affairs Specialist > Machelen > Joboolo BE :
Company : Oxford Global Resources Location : Machelen Flanders From : Talent BE
Tasks & Responsibilities:
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 regulatoryaffairs 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.
Requirements:
Life Sciences background.Basic regulatoryaffairs 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 regulatoryaffairs 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. OxfordGlobalResources MachelenFlanders
