Regulatory Affairs Manager/Expert - 製薬 会社

勤務地 Tokyo, Japan
職種 正社員
給与 ¥10000000.00 - ¥11000000.00 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-1909-426154
see Yuichi's jobs

[Company Description]
Global Pharmaceutical Company

[Responsibilities]
Regulatory Affairs Manager/Expert

  • Represent Development RA group in the responsible Project Team
  • Develop submission plan in collaboration with RPM and manage/coordinate preparation of all regulatory documentation, i.e. briefing document for PMDA consultation, CTN documents, JNDA documents (CTD), etc.
  • Develop regulatory strategy for each project
  • Create HA interaction plan
  • Represent the Company in any interactions with HAs
  • Review and provide regulatory input to all regulatory documentation
  • Collect and analyze updated regulatory-related information and share with the relevant people

[Requirements]

  • 5 or more years of experience of regulatory affairs in pharmaceutical industry
  • Proven expertise in development and management of regulatory strategy for Japan
  • Demonstrated experience in interaction with HAs in Japan
  • Experience of regulatory affairs in in vitro diagnostics/companion diagnostics development (preferable)
  • Business level English

[Desired Characteristics]

  • Proven leadership and management skills in the functional and cross-functional team
  • Good interpersonal communication skill
  • Negotiation skill
  • Business-orienting thinking

[Employment Type]
Full time

[Salary]
10-11M
(Experiences and skills will be considered)

[Location]
Tokyo

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