CMC Regulatory Expert Global Pharmaceutical Company Hungary

4 days ago


Budapest, Budapest, Hungary Carbyne Full time 60,000 - 120,000 per year

For our multinational pharmaceutical partner we are in search of a CMC Regulatory Manager to join this exciting role supporting the company's growth which includes a major site-to-site technology transfer project in Hungary.

Key Responsibilities:

  • Overseeing the preparation of regulatory submission documents.
  • Ensuring regulatory compliance for pharmaceutical products at all stages of their lifecycle
  • Collaborating with internal teams (both parent and subsidiary companies) and external experts.
  • Providing professional support for new marketing authorization applications and ongoing regulatory maintenance tasks
  • Addressing regulatory queries and preparing comprehensive responses
  • Handling administrative and documentation-related tasks within the marketing authorization dossier management system

Requirements:

  • Degree in Life Sciences (Biology, Chemistry, Pharmacy, stb.)
  • Fluent in English and Hungarian
  • At least 2 years of regulatory experience preferably in CMC (writing or reviewing)

Should you be interested please do not hesitate to submit your professional CV.



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