CAC & Distribution Markets Regulatory Affairs Specialist
On-siteInsurgentes, Estado de Veracruz-Llave, Mexico
Job Summary
Conduct product registration submissions, progress reports, supplements, and amendments while maintaining product licenses for CMC, CDS, and safety updates in alignment with local regulations. Ensure compliance with NP4, KRPIA, and DRAGON guidelines by managing technical complaints, adverse events, and special case scenarios reported within 24 hours. Distribute marketing samples where applicable and foster relations with internal and external stakeholders. Maintain product licenses according to company strategy and global compliance standards. Requires minimum two years of regulatory experience in Latin America, knowledge of local pharmaceutical laws, and proficiency in regulatory databases.
Required Qualifications
- Minimum of 2 years of experience in Regulatory Affairs within Latin American countries
- Experience with regulatory submissions and lifecycle management activities for pharmaceutical products
- Knowledge of applicable pharmaceutical regulations in at least one Latin American country
- Experience using regulatory and quality databases
- Proactive, detail-oriented, and capable of managing multiple projects simultaneously
- Strong ability to work independently
Desired Qualifications
- Analytical Skill
- Clinical Trials
- Collaboration
- Detail-Oriented
- Lifesciences
- Project Planning
- Regulatory Compliance
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