薬事機能リーダー / Regulatory Leader

PMDA / MHLW / FDA / EMA / China / Taiwan / Korea）を行う。

CMC、非臨床、臨床、安全性）のメンバーで構成される申請・審査対応チームを統括し、国内申請・審査対応計画の立案・実行を行う。

Global regulatory leader及び中外の海外子会社と連携、協働する。

Background to appointment :

Recruiting a talented experienced Regulatory expert, in order to address increasing Japanese NDA filings as well as increasing global development products.

Description of work :

As for products development in Oncology, Neuroscience, Immunology and other disease areas and other novel modalities :

• To provide regulatory strategies and lead negotiation with health authorities (PMDA / MHLW / FDA / EMA / China / Taiwan / Korea) through development phase to post-approval phase;
• To establish a filing strategy / plan and implement Japanese NDA filing towards approval, by leading NDA filing team consist of related function members (CMC / non-clin / Clinical / Safety);
• To work and collaborate with Roche global regulatory leader and Chugai affiliates. 応募資格／Qualifications 求める経験：

5年以上の薬事経験

IND / CTA等）があれば尚望ましい

ICHガイドライン含）に関する知識

TOEICを含む）：

TOEIC・730点

Desired experience :

A minimum 5 years regulatory affairs experience

Experience working with cross-functional project team

Experience working with global regulatory activities (e.g. IND / CTA / HA meetings in US, EU and / or Asia) is highly preferred

Desired skills / knowledge / abilities :

Strong knowledge of Japanese regulations / guidelines (including ICH GL)

Ability of Problem Solving Approach including assessing situations from multifaceted viewpoints, extracting regulatory problems / challenges and proposing solutions and risk mitigation plan.

Management capability to establihsh relationship and proceed project across multi-functional members

Ability of negotiation skill based on scientific discussion.

Fluent in Japanese language skills including reading, writing, strategic thinking and communication

Desired competencies :

Achieve strategic goal emphasizing cross-functional cooperation.

Self-learning attitude to deepen understanding and knowledge with curiosity.

Self-motivated attitude to work independently and passionately addressing difficulties.

Desired Qualification：

TOIEC score over 730 points

Position Features：

Many opportunities for NDAs based on rich pipelines. Providing sufficient training opportunities internally and externally. 待遇／Salary & Benefits 当社規定により優遇いたします。

To be decided in accordance with our criteria.

Flextime system

The notification of working conditions will be made in an electronic file.

If you apply, please understand this point.