Regulatory Affairs Specialist

Regulatory Affairs SpecialistThe 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 :Regulatory Affairs Specialist Responsibility to ensure that regulatory submissions and compliance are executed for all products in a given country or region. Develop and communicate with head office on the regulatory strategy and life cycle management of all products in the count. Helping to update company's database and archives. Responsibilities: Regulatory Plan/Execution Ensure logistics support for the local registration Dossier Preparation/Compliance Check/Submission Collect, update and maintain appropriate scientific data and documentation needed to assess impact Ensure data collection and database updates and archive May assist Zone Manager LOQ Answer/Submission/Interaction with Authority Collect, update technical and administrative documentation if required, and maintain appropriate scientific data and documentation needed to prepare variations and renewal dossiers and to ensure answers to list of questions in a timely manner Maintenance and LCM Support Zone RA manager in assigned projects and related activities Helping to update the company’s database and achieve if necessary Knowledge and Intelligence Management Collect and maintain regulatory requirements of countries Archive all submitted documents Maintain tools, databases and process Competencies: Drive Ambition & Accountabilities Influence Others Collaborate with Empathy Engage & Develop Shape Solutions out of Complexity Client Focus Qualifications:BS or BA in science field or relevant work experience required1+ year of relevant experience possessing a BS/BA; 4+ years of relevant experience without possession of a BS/BAExperience with CFIA regulations or business for biologics, preferredStrong written and verbal communication skillsExcellent interpersonal and networking skillsAbility to organize and prioritize multiple tasksAbility to work independentlyDecision making and attention to detailDisclosures: This requisition is for a current opening at our Guelph, ON facility Targeted annual salary between $70-80k but may vary upon education, skills and experience Your profile :Qualifications:BS or BA in science field or relevant work experience required1+ year of relevant experience possessing a BS/BA; 4+ years of relevant experience without possession of a BS/BAExperience with CFIA regulations or business for biologics, preferredStrong written and verbal communication skillsExcellent interpersonal and networking skillsAbility to organize and prioritize multiple tasksAbility to work independentlyDecision making and attention to detail