Regulatory Affairs Manager
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.
-
Tokyo BD ￥25,000,000 - ￥35,000,000 per year· BD 안세요 전속,Waters Corp.첟BD안세요 전속,Waters Corp. ...
-
Minato-ku BD Full time￥1,584,000 - ￥2,442,000 per year薬事担当シニアマネージャーは、ライフサイエンス部門の薬事機能を統括し、バイオサイエンス事業部と診断ソリューション事業部の両方を統括します。体外診断用医薬品(IVD)関連規制を含む国内外の規制へのコンプライアンスを確保するための薬事戦略の策定と実行을担当します。 · ...
-
Tokyo BD ￥100,000 - ￥200,000 per year+ · + · +h2+bJob summary/b/h2+pThe Senior Manager responsible for all aspects of regulatory affairs for BDB and DS./ppressible for all aspects of regulatory affairs for BDB and DS.+h2+bJob Description Summary/b/h2+pResponsible for all aspects of regulatory affairs +/pposition ove ...
-
Minato-ku BD Full time￥6,000,000 - ￥12,000,000 per year호소는 정을 안세요 - · BD's Life Science Department (BioScience and Diagnostic Solutions Business) is integrating with Waters to become a leading company in the life science and diagnostic fields, specializing in high-volume testing in a highly regulated market. · ...
-
Tokyo BD ￥2,024,000 - ￥30,000,000 per year当社のライフサイエンス製品に関する薬事業務全般をご担当いただきます。具体的には以下の業務を担っていただきます。 · 製品登録プロジェクトのリード · (医薬品医療機器等法)に基づく登録申請書類の作成・提出 · 償還関連業務 · 区分の償還申請書類の作成・提出、E2・E3区分の償還取得サポート · 製品ラベリングのレビュー・承認 · 登録書類と整合性を保つためのラベルや関連資料の確認 · 広告・販促資材(AdProm) のレビュー・承認 · 事業部門:ビジネス戦略を理解し、薬事戦略や進捗を共有 · Regulatory(海外):製品登録に必要な情報のはて ...
-
Tokyo The businesses of Merck KGaA, Darmstadt, Germany Full timeLife Science Regulatory Management、レギュラリースペシャリストとして業務を行う。東京勤務、週2日在宅ワーク可。 · ...
-
Tokyo BD ￥9,000,000 - ￥12,000,000 per year+仅：department · ） +先 · ...
-
Japan Ceva Sante AnimaleCeva Animal Health believes the success of a company depends on the passionate people we partner with. Together, let's share our talents and contribute to the future of our diverse planet by researching, developing , producing and supplying innovative health solutions for all ani ...
-
Japan ColgateSupports Associate Director Regulatory Affairs EMEA/Japan to ensure compliance with regulations and statutes concerning development, manufacturing, distribution, marketing and sales of Hill's products in Japan. Develops creative approaches and strategies to solve regulatory probl ...
-
Regulatory Affairs
4週間前
Tokyo ZOLL Medical Corporation ￥6,000,000 - ￥9,000,000 per yearThe Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.This position will also oversee the preparati ...
-
Tokyo ICON plc ￥800,000 - ￥1,200,000 per yearSenior Manager, Regulatory Affairs - Tokyo Osaka Remote/office hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mis ...
-
Tokyo, Tokyo iNova Pharmaceuticals ￥4,500,000 - ￥8,000,000 per yearThe Company is seeking a Regulatory Affairs Manager to join its team on a full-time basis. The position is responsible for setting & executing the Japan regulatory strategy, managing product registration and maintenance, local regulatory support for the new product launch and loc ...
-
Tokyo IFF ￥60,000 - ￥120,000 per yearAre you passionate about advancing health and wellness through innovative bioscience solutions? · Channeling our passion for nature and bioscience into sustainable, life-enhancing technologies that power innovative solutions across healthcare, food, consumer and industrial market ...
-
Greater Tokyo Area Kingfisher HR Solutions GroupThis position offers a unique opportunity for growth with an international cosmetics manufacturer expanding into Japan. · The role involves managing compliance systems for pharmaceuticals , quasi-drugs ,and cosmetics . · ...
-
Regulatory Affairs
4週間前
Tokyo ZOLL Medical Corporation ￥5,500,000 - ￥10,000,000 per yearThe Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.This position will also oversee the preparati ...
-
Tokyo Merck Ltd. Full timeMerck is seeking a Regulatory Affairs Expert to perform tasks such as preparation and submission of DMF for APIs and excipients. · ...
-
Japan MerckMerck is looking for a Regulatory Affairs Expert to work in collaboration with regulatory experts to perform various tasks such as preparation, submission, and maintenance of DMF for APIs and excipients. · ...
-
Tokyo Hoya Vision Care ￥800,000 - ￥1,200,000 per yearThe Cluster Senior Regulatory Affairs Manager will develop and maintain regulatory strategies for marketing authorization applications in cluster countries, ensuring compliance with global and regional requirements. The role involves monitoring operational progression of pre-mark ...
-
Tokyo ICON plc ￥800,000 - ￥1,200,000 per yearSenior Manager, Regulatory Affairs - Tokyo Osaka Remote/office hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mis ...
-
Minato Novartis ￥4,000,000 - ￥8,000,000 per yearContribute to the overall activities in drug development toward obtaining the marketing authorization and maintenance activities of post marketing products in assigned TA. · Assist developing innovative and high quality regulatory strategies to facilitate regulatory processes in ...
-
Shinjuku Cordis Full time￥5,000,000 - ￥10,000,000 per yearThis position will be responsible for leading all medical device Regulatory Affairs activities which include product submissions, develop regulatory strategies, change assessments, commercial supports, compliance related activities, systems/process improvements and other responsi ...
