Regulatory Affairs Expert

hace 5 horas


Xico, México Theramex A tiempo completo

Job Summary: Theramex is seeking a skilled Regulatory Affairs Analyst to join our team in Mexico. As a Regulatory Affairs Analyst, you will be responsible for ensuring the company's products comply with COFEPRIS regulations.

About the Role

This role involves preparing, reviewing, and submitting registration applications for new products, as well as managing product lifecycle and staying up-to-date with national legislation.

Key Responsibilities
  • Prepare, review, and submit registration applications for new products, including synthetics and biologicals
  • Manage product lifecycle, ensuring compliance with COFEPRIS regulations
  • Stay aware of national legislation and its updates
  • Review and approve promotional materials and package designs
Requirements
  • Pharmacy degree from an accredited institution
  • At least 3 years of professional experience in drug registration and post-registration
  • Advanced English language skills
  • Reliability, responsibility, organization, commitment, flexibility, and proactivity
Estimated Salary Range: $800,000 - $1,200,000 MXN per year

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