Pharmaceutical Regulatory Compliance Expert

1 week ago


Islamabad, Islamabad, Pakistan beBee Careers Full time

Regulatory Affairs Specialist

Nuvex Biotech is a growing Contract Development and Manufacturing Organization (CDMO) focused on formulation optimization and drug development support. As we expand our regulatory support services, we're seeking a Regulatory Consultant with expertise in drug registration, dossier preparation, and compliance strategies across local and global markets.

Key Responsibilities:

  • Prepare/review Clinical Trial Dossiers (CTDs)
  • Navigate licensing and regulatory submissions in the Drug Regulatory Authority of Pakistan (DRAP) and other international markets
  • Advise on compliance strategies adhering to Good Manufacturing Practice (GMP), International Conference on Harmonisation (ICH), and European Medicines Agency (EMA) guidelines
  • Provide documentation and audit-readiness support to ensure regulatory confidence

Requirements:

  • At least 5 years of experience in regulatory affairs within the pharmaceutical industry
  • A strong understanding of DRAP, ICH, and preferred US FDA/EMA/GCC requirements
  • A solid grasp of documentation and regulatory frameworks
  • Proactive, detail-oriented, and comfortable working with lean teams

Becoming Part of Our Team

By joining us, you will contribute to the development of innovative formulations while maintaining regulatory compliance. If you are passionate about your work and want to make a meaningful impact, please explore this opportunity further.



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