15 ago
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Theramex
|
Ciudad de México
15 ago
Theramex
Ciudad de México
**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 ANVISA
📌 Regulatory Affairs Analyst (Ciudad de México)
🏢 Theramex
📍 Ciudad de México