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Regulatory Affairs Manager: Ensuring Compliance and Efficiency
This position involves ensuring the quality and efficiency of Regulatory Affairs activities, complying with regulatory standards, and providing support for the activities of the Regulatory area.
Responsibilities:- Manage and control product registrations in various countries.
- Organize and execute product dossiers. Prepare and assemble product dossiers for later registration in Brazil and other South America countries.
- Monitor the progress of processes along MAPA websites.
- Assist in executing product registration processes, adjustments, and updates with MAPA.
- Keep accurate records and notify relevant authorities.
- Perform license renewals before relevant bodies (MAPA), ensuring timely submission of processes with necessary documentation.
- Control, prepare, and check documents from Quality Assurance, Marketing, and Production areas, ensuring compliance with approved documents by MAPA.
- Contribute to maintaining current quality certifications through evaluation and review of procedures and forms.
- Bachelor Degree in Veterinary Medicine or Animal Science.
- Professional background in Regulatory Affairs in Vaccine segment.
- Knowledge of MAPA legislation.
- Negotiation skills with external bodies.
- Computer knowledge (MS Office).
- Good Manufacturing Practices knowledge.
- CRMV-SP active.
- Fluent English/Intermediate Spanish.
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