• Contribute to regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.
  • To contribute to the production of client administrative documents to be included in regulatory submissions
  • Compile regulatory dossiers in accordance with national requirements.
  • Systems Management and Administration
  • Document and track regulatory submissions and regulatory authority approval.
  • Provide regulatory support to clients and associate companies.
  • Liaise with sponsor head-office and affiliate departments on regulatory issues.
  • Provide review of packaging texts.
  • Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
  • Provide on-going regulatory support to the Regulatory Affairs Specialist and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
  • Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services supplied by the platform/hub.


    • knowledge and experience in regulatory submission activities within the EEA, focus: Lifecycle management (variations, renewals, etc.)
    • experience in regulatory affairs within the generic industry (large portfolio, high number of products to be handled)
    • experience in the handling of eCTD dossiers
    • experience in change control activities within the pharmaceutical environment
    • solid command of English
    • highly flexible and adaptable personality
    • strong team player qualities

Regulatory Affairs Manager (Freelancing) 755