Country: Hungary
Functional area: Regulatory Affairs

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.

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.