Regulatory Affairs Analyst (Mid-Level)
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.
Your
missions :
• Preparing
documentation for regulatory processes to be filed with regulatory bodies;
• Renewing licenses for products and establishments before the relevant bodies (MAPA, ANVISA, professional councils,among others), ensuring that processes are submitted within the legal timeframe and with the necessary documentation;
• Monitoring the progress of processes with
regulatory bodies;
• Updating the registrationdata of Ceva Brazil subsidiaries and their technical managers with thecorrespondingbodies;
• Preparing and requesting the necessary documents from official bodies for the import
and export of veterinary products, submitting the requested documents and makingthem available to the requesting areas;
• Controlling, preparing, and organizing production, product import and export maps; maps ofofficially controlled products and substances (periodic reports), in compliance with
current regulations, sharing activitieswith other areas of thecompany;
• Assisting in the execution of product registration processes, adjustments, and updates
with MAPA;
• Prepare and control the documentation for the collection of vaccines for official control
by MAPA and monitor the official
results, and ensure that they are in accordance with
current regulations and madeavailable to the various sectors within
the established timeframe;
• Assisting in meeting MAPA requirements, participating in the review and assemblyof dossiers and response processes;
• Checking the wording on packaging,advertising leaflets and technical bulletins, ensuring
that they comply with documents approved by MAPA (approved forms, technical reports, etc.);
• Checking
documents from
the Quality
Assurance and Production areas,
such as manufacturing instructions, specifications, and Certificates
of Analysis, ensuring their conformity with documents approved by MAPA (licenses, approved forms, technical reports, among others);
• Assisting in the assembly and organization of product dossiers for subsequent official submission;
• Updating outsourcing contracts(contractor and contracted), ensuringthat they are up to date with
therelevant bodies;
• Support Ceva's subsidiaries in the regulatory area by providing relevant documentation for veterinaryproducts produced in Brazil and other information required;
• Assisting in the sharing of documents for products manufactured in Brazil and exported to other countries.
Your
profile :
• Complete university degree or studying Veterinary Medicine
• National legislation on veterinary establishments and
products
• Electronic submission systems of the relevant bodies, mainly MAPA
• Knowledge of Good Manufacturing Practices (National and International)
• Advanced English
