Johnson & Johnson Careers

【Medical Company】Regulatory Affairs Senior Manager (or Director) for Ethicon

Chiyoda, Japan
Regulatory Affairs


Job Description

Requisition ID: 1701954670W

<職務内容>
・薬事戦略の構築
・規制・審査当局との交渉
・ビジネスサイド、製造元とのパートナーシップ
・グローバル/リージョンRAとのコミュニケーション
・Manager, Staffの育成とチームマネジメント
 ※新卒を含む若手も多い組織です
   ※申請資料の作成や当局対応の進め方も指導していただくことを期待しています


<Job Description>
· Construct Regulatory strategy
· Negotiation with regulatory authorities including PMDA
· Partnership with Business functions and manufacturer
· Communication with global / region RA
· Development of team members. Team management
* This team consist of junior members including new grads
  * We expect you to instruct members how to prepare application materials and how to cope with Ministry/PMDA.



Qualifications
<職務経験>
・ピープルマネジメントの経験
(若手のマネージャーや新卒の育成経験があると尚可)
・医療機器もしくは医薬品メーカーでの薬事申請・当局対応の経験
(7-10年以上が望ましい、外科領域の経験があると尚可)

<必要とする能力・スキル>
・海外とのコミュニケーション
(ネゴシエーションができるレベル、海外赴任・在住経験があると尚可)

<資格/免許>
特に無し

<提出書類>
履歴書・職務経歴書(英語・日本語の両方必要)


<Job experience >
· People management experience
(It is highly regarded if you have managed young managers and new graduates)
· New medical device or new drug application experience including negotiation with Ministry and PMD.
(7 - 10 years or more experience desirable, especially dealing with surgical products)

<Required skills and skills>
· Communication with global or region
(Business level English good enough to negotiate with native English speakers. It is preferable to have experience of living and working abroad.)



Primary Location
Japan-Tokyo-To-Chiyoda
Organization
Johnson & Johnson K.K. (8235)
Job Function
Regulatory Affairs
Requisition ID
1701954670W