Regulatory Affair PL.
Analyst
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 Health 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.
Your missions:
Prepare documentation for regulatory processes to be submitted to regulatory authorities;
Handle the renewal of product and establishment licenses with relevant authorities (MAPA, Anvisa, professional councils, among others), ensuring the submission of processes within legal deadlines and with the required documentation;
Monitor the progress of processes with regulatory authorities;
Update the registration data of Ceva Brasil branches and their technical representatives with the relevant authorities;
Prepare and request necessary documents from official authorities for the importation of veterinary products, submitting the requested documents and making them available to requesting areas;
Assist in the execution of product registration processes, adjustments, and updates with MAPA;
Prepare and control documentation for the collection of vaccines for official control by MAPA, monitor official results, ensure compliance with current regulations, and make them available to various departments within the established timeframe;
Assist in meeting requirements with MAPA by participating in the review and preparation of dossiers and response processes;
Verify the labeling of packaging, promotional brochures, and technical bulletins to ensure compliance with documents approved by MAPA (approved prints, technical reports, etc.
);
Ensure the compliance of documents approved by MAPA (licenses, approved prints, technical reports, among others);
Assist in the preparation and organization of product dossiers for subsequent official submission;
Update outsourcing contracts (contractor and contracted parties), ensuring their compliance with relevant authorities;
Support Ceva branches in regulatory matters by providing relevant documentation for veterinary products manufactured in Brazil and other requested information.
Your profile:
Completed or ongoing degree in Veterinary Medicine;
Knowledge of national legislation related to veterinary establishments and products;
Familiarity with electronic submission systems of relevant authorities, especially MAPA;
Knowledge of Good Manufacturing Practices (national and international);
Advanced English proficiency.
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