Overview
Regulatory Affairs Manager Jobs in Yokohama, Kanagawa, Japan at CEVA SANTE ANIMALE
Title: Regulatory Affairs Manager
Company: CEVA SANTE ANIMALE
Location: Yokohama, Kanagawa, Japan
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
As Regulatory Affairs country manager, to ensure that regulatory submissions and post-licensing compliance are executed for all Ceva products according to the local law; to coordinate the activities necessary to achieve and maintain appropriate permits, licenses and other documentation required to be in compliance with appropriate regulatory authorities. To apply the regulation to the company in order to make business smoothly, checking the artwork and approval for artwork label and leaflet; to develop and communicate with head office on the regulatory strategy and life cycle management of all products in the country.
As Affiliate Quality Officer, ensure that a quality system is implemented and maintained, following all the specific responsibilities of this position.
As Pharmacovigilance national contact, to manage the local Pharmacovigilance activities following the Corporate procedures, to follow the corporate procedures, to generate local procedures if required and to ensure that any additional local requirements are met. To ensure the activities continuity.
As Public Affairs from Ceva affiliate, to support offensive and defensive regulatory work on their countries focused on the local regulatory affairs, through good networking with authorities and other third parties. To represent CEVA as the contact person for the local Authorities and other external partners.
Your Profile
Bachelor’s or Master’s degree in Life Sciences, Veterinary Medicine, Pharmacy, or a related field.
Several years of experience in regulatory affairs, particularly within the veterinary pharmaceutical industry.
Experience in managing regulatory submissions, registrations, and compliance with veterinary pharmaceutical regulations.
Strong knowledge of regulatory requirements and guidelines for veterinary products.
Excellent project management skills, including the ability to plan and execute regulatory submissions.
Ability to communicate effectively with regulatory authorities and internal stakeholders.
