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Theramex career site
Regulatory Affairs · Mexico City

Regulatory Affairs Analyst

For Women, For Health

Job Purpose

Act as responsible for obtaining and maintaining Theramex product registrations and licenses in compliance with COFEPRIS regulations. Collaborate with our headquarters and coordinate third parties related to regulatory affairs.

Key Duties and Responsibilities

  • Prepare, review and submit registration for new products (focus on synthetics and biologicals)
  • Prepare, review and submit post-registrations and changes
  • Manage product lifecycle
  • Be aware of national legislation and its updates
  • Review and approve promotional materials
  • Review and approve package materials

Minimum Requirements (Experience & Education)

  • Pharmacy degree
  • At least 3 years of professional experience with drug registration and post-registration
  • Advanced English
  • Reliability, responsibility, organization, commitment, flexibility, proactivity
  • Solid knowledge in evaluating technical documentation for the preparation of registration dossiers, creation, and submission of registration and post-registration processes to COFEPRIS 
Department
Regulatory Affairs
Locations
Mexico City

About Theramex

We are Theramex, a global specialty pharmaceutical company solely committed to supporting the health needs of women through every stage of life.

We work closely with our partners, healthcare professionals, and patients to help women find the solution that may be right for them at the time they most need it.

 

Founded in 2018
Co-workers 500+
Regulatory Affairs · Mexico City

Regulatory Affairs Analyst

For Women, For Health

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