Regulatory Affairs Specialist

CEVA Logistics; Paulínia; On-site; BRL 90,000 - 170,000; Full time

Job summary

Ceva Animal Health in Brazil seeks a Regulatory Affairs Specialist to prepare and submit regulatory documentation, renew licenses, and monitor submissions with MAPA, ANVISA, and councils. You will update branch registrations and manage documentation for import/export of veterinary products, collaborating with multiple departments to ensure regulatory compliance.

The role requires a veterinary/biochemical background, GMP knowledge, and advanced English.

Qualifications

• Bachelor’s degree in Veterinary Medicine, Pharmacy, or Biochemistry.
• Experience with GMP and regulatory submissions.
• Knowledge of MAPA electronic submission systems.
• Advanced English; Spanish desirable.

Responsibilities

• Prepare regulatory documentation for procedures to be submitted to authorities.
• Manage renewal of product and establishment licenses with MAPA, ANVISA and councils.
• Monitor progress of applications with local and international authorities.
• Update registration data of Ceva Brazil branches and managers.
• Prepare documents for import/export of veterinary products.
• Prepare and maintain reports on products and substances under official control.

Skills

Advanced English

GMP compliance

Regulatory submissions

Cross-functional collaboration

Education

Bachelor’s degree in Veterinary Medicine, Pharmacy, or Biochemistry

Tools

MAPA submission system

Job description

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.