Regulatory affairs specialist – Paulínia/SP

Responsabilidades

• Prepare documentation for regulatory procedures to be submitted to regulatory authorities.
• Manage the renewal of product and establishment licenses with the relevant authorities (MAPA, ANVISA, professional councils, among others), ensuring that applications are submitted within statutory deadlines and include all required documentation.
• Monitor the progress of applications with local and international regulatory authorities.
• Update the registration data of empresa’s branches in Brazil and their technical managers with the relevant authorities.
• Prepare and request official documents required for the import and export of veterinary products, submitting the necessary documentation and making it available to the requesting departments.
• Prepare, organize, and maintain production, import, and export reports, as well as periodic reports on products and substances subject to official control, in compliance with current regulations and in collaboration with other departments.
• Support product registration processes, amendments, and updates with national and international regulatory authorities.
• Prepare and manage the documentation required for the collection of vaccines subject to MAPA official control, monitor official results, ensure compliance with current regulations, and make the information available to the relevant departments within the established deadlines.
• Support responses to regulatory requests in partnership with regulatory teams in Brazil and other countries, participating in the review and preparation of dossiers and response submissions.
• Review packaging text, advertising materials, and technical bulletins, ensuring compliance with documents approved by the authorities, such as approved printed materials and technical reports.
• Review documents from the Quality Assurance and Production departments, including manufacturing instructions, specifications, and Certificates of Analysis, ensuring compliance with documents approved by regulatory authorities.
• Support the preparation and organization of product dossiers for official submission.
• Update outsourcing agreements between contracting parties and service providers, ensuring that they remain current with the relevant authorities.
• Provide regulatory support to empresa’s subsidiaries by supplying relevant documentation for veterinary products manufactured in Brazil and other requested information.
• Support the rollout and implementation of global tools for filing and managing regulatory documentation in accordance with the company’s corporate guidelines.

Requisitos

• Bachelor’s degree in Veterinary Medicine, Pharmacy, or Biochemistry.
• Knowledge of national and/or international legislation related to Good Manufacturing Practices and the registration of medicinal or veterinary products.
• Previous experience in the animal health, animal nutrition, or human pharmaceutical industry.
• Experience with electronic submission systems used by the relevant regulatory authorities, particularly MAPA.
• Knowledge of national and international Good Manufacturing Practices (GMP).
• Advanced English.
• Intermediate Spanish is desirable.

Marcado como: ANVISA, Assuntos Regulatórios, BPF, Legislação Sanitária, Produtos Veterinários, Registro de Produtos