FSP Regulatory Affairs Specialist - CMC Compliance Officer client dedicated

Regulatory Affairs Specialist supporting CMC compliance and regulatory operations at Thermo Fisher Scientific. The role involves managing change controls, deviations, annual reports, and health authority commitments across product lifecycles in a remote position based in Belgium.

Responsibilities

• Maintain change control trackers, coordinate implementation dates with CMOs, manage review boards, and monitor KPI dashboards
• Establish and manage deviations tracking system in partnership with Quality teams and CMOs
• Prepare annual regulatory reports, extract compliance data, and facilitate cross-functional alignment per jurisdiction
• Track health authority commitments, coordinate technical activities, and ensure timely study initiation
• Coordinate excipient compliance with regional pharmacopoeia requirements and compendial updates

Requirements

• Degree in biotechnology, pharmaceutical sciences, or bioengineering
• CMC project management or quality and compliance background in biotech industry
• Knowledge of medical device and IVD regulations (EU MDR/IVDR, FDA, international)
• Experience with regulatory submissions and documentation management
• Strong technical writing and documentation skills; proficiency in Microsoft Office
• GMP, ISO 13485, and quality management systems knowledge
• Fluent English communication; ability to manage multiple projects across time zones