Regulatory Affairs Specialist

CEVA Logistics; Brasil; Teletrabalho; BRL 120 000 - 180 000; Tempo integral

Resumo da oferta

Ceva Animal Health in Brazil seeks a Regulatory Affairs Specialist to prepare documentation for regulatory submissions and manage license renewals with national authorities such as MAPA and ANVISA. You will monitor ongoing regulatory actions, update branch registrations, and coordinate import/export documentation with multiple departments.

The role requires a veterinary/pharmacy/biochemistry degree, GMP knowledge, MAPA experience, and advanced English.

Qualificações

• Bachelor's degree in Veterinary Medicine, Pharmacy, or Biochemistry.
• Knowledge of national/international GMP and registration rules.
• Experience with MAPA e-submission systems.
• Advanced English; Spanish is desirable.

Responsabilidades

• Prepare documentation for regulatory procedures submitted to regulatory authorities.
• Manage renewal of product and establishment licenses with MAPA, ANVISA, and professional councils.
• Monitor progress of applications with local and international authorities.
• Update registration data for Ceva Brazil’s branches and technical managers.
• Prepare and request documents for import/export of veterinary products and make them available to relevant departments.
• Produce and maintain production, import, and export reports and reports on products subject to official control.
• Support product registration processes, amendments, and updates with authorities.
• Prepare and manage documentation for collection of vaccines under MAPA control and monitor official results.
• Support responses to regulatory requests in partnership with Brazil and other countries.
• Review packaging text, advertising materials, and technical bulletins for regulatory compliance.
• Review QA and Production docs including manufacturing instructions, specifications, and COAs for regulatory compliance.
• Assist in preparing and organizing product dossiers for official submission.
• Update outsourcing agreements to stay current with authorities.
• Provide regulatory support to Ceva’s subsidiaries with documentation for Brazilian-made products.
• Assist rollout of global tools for filing and managing regulatory documents.

Conhecimentos

Regulatory knowledge

English proficiency

Spanish (intermediate)

Formação académica

Bachelor's in veterinary/pharmacy/biochemistry

Ferramentas

MAPA electronic submission system

Descrição da oferta de emprego

Regulatory Affairs Specialist

The success of a company depends on the passionate people we partner with. Together, let's share our talents. As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet. We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife. Indeed, Our “Together, Beyond Animal Health” vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.

As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

Yourmissions :

• 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 Ceva Brazil’s branches 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 Ceva’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.

Yourprofile :

• 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.