Director, Regulatory Affairs(部長)- Pharmaceutical Company

勤務地 Tokyo, Japan
職種 正社員
給与 ¥18000000.00 - ¥22000000.00 per annum
専門 ライフサイエンス・ヘルスケア・医療機器・製薬,
Sub-specialization 薬事,
お問合せ Yuichi Matsuda
参照 JO-1911-429675
see Yuichi's jobs

[Company Description]
Global Pharmaceutical Company

[Responsibilities]
Director, Regulatory Affairs

Acts as a supervisor of new regulatory staff, driving the submission globally for assigned products, preparing regulatory strategies and evaluating risk assessment, liaison with country Regulatory Managers, interactions with the relevant manufacturing sites.

  • Responsible for driving the submission globally for assigned products: approvals and renewals according to marketing needs, managing the preparation, content and format of the submissions
  • Liaison with health Authorities and internal and external Experts, with country Regulatory Managers, interactions with the relevant manufacturing sites
  • Responsible for driving clinical trial applications
  • Providing data packages according to local requirements, Preparations of prescribing documents ( SPCs, Package inserts, labels)
  • Preparing regulatory strategies and evaluating risk assessment. Evaluation and assessment of regulatory requirements for variations, extensions and New MAAs .
  • Due diligence participation
  • Providing advice on ICH/Intercon regulatory legislation, support intercom group
  • Data entry (GRAB), document handling (REAL)
  • Responsible for continuously development knowledge and finding innovative solutions to regulatory problems
  • Monitoring and training of new regulatory staff

[Requirements]

  • A degree in Life Science or Pharmacy
  • 5-10 years experience in Regulatory Affairs or equivalent
  • Perfect knowledge of current rules and procedures for product registration
  • Fluency in English and local language
  • Good computer skills
  • Good Negotiation skills

[Employment Type]
Full time

[Salary]
18-22M
(Experiences and skills will be considered)

[Location]
Tokyo

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