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Regulatory Affairs Consultant

3 months ago


London, Greater London, United Kingdom Lifelancer Ltd Full time

Regulatory Affairs Consultant Position at XYZ Pharmaceuticals

  • Over 8 years of experience managing life cycle of approved drug products such as tablets, syrups, and injectables for EU market
  • Deep understanding of regulatory framework and regional trends for various types of applications
  • Leading and participating in the planning and delivery of regulatory submissions on a global and/or regional scale
  • Familiarity with EU/US regulatory procedures and post-approval requirements
  • Experience in handling CMC-related health authority queries
  • Knowledge of global pharmaceutical legislation and guidance related to regulatory aspects in ICH countries
  • Collaborating closely with cross-functional team members
  • Developing and maintaining submission delivery plans
  • Preparing and submitting safety variations to Health Authorities
  • Familiarity with Regulatory Information Management Systems like Veeva Vault is a plus
  • Strong communication and ability to work independently