Regulatory Affairs Manager

2 semanas atrás

Valinhos, Brasil Kemin Tempo inteiro

Overview:
Responsibility for ensuring the quality and efficiency of Regulatory Affairs activities, complying with regulatory standards and providing support for the activities of the Regulatory area, managing and performing tasks related to routines of registration, control and maintenance of records of products for animal health and establishments.

**Responsibilities**:

- Manage and control the registration of the company's products and new products, in the process of being launched.
- Organize and execute the company's product dossiers. Caring out the preparation and assembly of the company's product dossiers for later registration in Brazil and other South America countries
- Monitor the progress of processes along MAPA websites.
- Assist in the execution of product registration processes, adjustments and updates with MAPA.
- Keep the company's register and itps technical responsible before the competent bodies such as CRMV, MAPA, Sindam, etc.
- Perform product and establishment license renewals before the relevant bodies (MAPA, CRMV), ensuring the submission of processes within the legal time and with the documentation necessary.
- Control, prepare and check documents from the Quality Assurance, Marketing and Production areas, such as ITF's, Specification Sheets and Certificates of Analysis, ensuring their compliance with documents approved by MAPA (licenses, approved forms, technical report, among others)
- Integrated action to the Food Safety Management System (GMP, HACCP and FSSC22000, among others, established by the company) through the evaluation and review of procedures and forms, aiming at maintaining the current quality certifications.

Qualifications:

- Bachelor Degree in Veterinary Medicine or Animal Science.- Professional background in the Regulatory Affairs in Vaccine segment.- MAPA legislation knowledge.- Negotiation with external bodies.- Computer knowledge (MS Office).- Good Manufacturing Practices knowledge.- CRMV-SP active.- Fluent in English / Intermediate Spanish.#LI-BM1

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