Regulatory Affairs Specialist: Pharmaceutical Compliance Expert

hace 3 semanas


Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

In the pharmaceutical industry, compliance with regulations is critical for the success of any project. As a Regulatory Affairs Specialist, you will play a key role in ensuring that our company, ProductLife Group, meets all regulatory requirements in Mexico and Central America.

Responsibilities:
  • Provide guidance and support on Mexican and Central America legislation
  • Contribute to pre-licensing activities, new registration, and post-licensing regulatory submissions
  • Produce client administrative documents for regulatory submissions
  • Compile regulatory dossiers according to national requirements
  • Manage systems and administration
  • Track and document regulatory submissions and authority approvals
  • Support clients and associate companies on regulatory issues
  • Liaise with sponsor head-office and affiliate departments on regulatory matters
  • Review packaging texts and format summaries of product characteristics
Requirements:
  • Bachelor's degree in a Life Sciences field or equivalent
  • 5+ years of experience in Regulatory Affairs in the pharmaceutical industry or as a service provider


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