メディカル・バイオ - 臨床開発QC・GCP監査
メディカル・バイオ - 薬事申請
メディカル・バイオ - 安全性情報（臨床開発・製販後GVP）
メディカル・バイオ - 製造販売後調査（GPMSP）
メディカル・バイオ - メディカルGQP・GMP・品質保証・品質管理
メディカル・バイオ - 品質保証
メディカル・バイオ - ＣＭＣ薬事

You main missions:
Ensuring the maintenance of our Marketing authorization licenses (MAL) for veterinary medicinal products
● Conducting regulatory evaluation and impact assessment of changes
● In collaboration with local teams and/or the Global Regulatory Affairs Team in France, preparing dossiers for variations submissions, minor change notifications and revision of precautions for use to the authorities.
● Leading consultations and effectively communicating with competent authorities to ensure the acceptance of Marketing Authorization applications
● Driving the submission of key strategic product opportunities, including additional indications and extended validity periods.
● Ensuring packaging accuracy by verifying the regulatory texts on packaging materials to be consistent with description of the MAL.

Management of LCM team
● Organizing and optimizing your team's resources to achieve set objectives.
● Developing and monitoring the schedule of regulatory actions.
● Coordinating, motivating and developing the skills of your team.
● Fostering an effective collaboration with the members of New registration team, Quality assurance team, Marketing team, Logistics team in order to define the most suitable regulatory options for each project

Regulatory Intelligence
● Organizing with the team a robust regulatory intelligence for LCM activity.
● Monitoring regulatory developments: actively analyzing and providing strategic comments on new draft regulatory texts, guidelines, and policies issued by competent authorities.
● Alerting management of potential risks and opportunities.

■休日：週休二日制, 年末年始

We are looking for someone with excellent interpersonal and communication skills, capable of working in project mode, demonstrating leadership and the ability to manage a team.

■職種未経験者：不可