開発薬事 - 製薬会社

Location: Tokyo, Japan
Job Type: 正社員
Salary ¥10000000.00 - ¥18000000.00 per annum
Specialization: ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産)
職種 薬事
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お問合せ Eureka Teramura
参照 JO-2012-452280
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※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[Company Description]
外資系製薬会社

  • 「世界で最も革新的な企業」に選ばれる高い技術力を持ち、世界初の医薬品を数々開発しています
  • 希少疾患のための薬を手がけています
  • 働き方の整備に積極的です

[Responsibilities]
■Position Summary
Senior Manager, Regulatory Affairs should be responsible for creating Japanese Package Inserts (JPIs; i.e. Japanese Labeling) of new drugs and manage revisions of JPIs of post approval products and review of educational materials (with the advice of Director or Associate Director as needed). Also review the process of promotional materials from Regulatory point of view. The duties include complying with Japan pharmaceutical affairs act, developing good relations with the regulatory authority, and performing pharmaceutical tasks required for product development and life cycle management in a timely and appropriate manner. Since labeling is a driver of all NDA documents, the role of this position should be specialist and experienced of JPI works.

■Principal Responsibilities

  • Creating Japanese Package Inserts of new drugs and manage revisions of JPIs of post approval products to be in line with CCDS.
  • Lead labeling committee in Japan for the JPI production schedule with involving other related divisions .
  • Review educational materials based on the Japanese Regulations and internal SOPs.
  • Review promotional materials aligning with Global Advertising & Promotion Compliance team.
  • Serving as a contact person for the company, coordinates for pharmaceutical affairs matters on each product 's JPI between internal concerned departments and regulatory authority.
  • Negotiate with subcontractors and external parties about pharmaceutical affairs issues as needed.
  • Assist Directors when it is necessary.
  • Coordinate with Global Labelling Team
  • Lead Global translation project for checking accuracy of translation of JPIs.

[Requirements]

  • More than 3 years' experiences of JPI in Regulatory Affairs.

[Employment Type]
Full time

[Salary]
10M-18M yen
※Experiences and skills will be considered

[Location]
Tokyo


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