JOB INFORMATION
求人情報

求人番号 73462-068

製薬・医療機器業界

外資系 メディカル

レギュラトリーポリシーインテリジェンスヘッド(JPAC)

  • 年収
    非公開
  • 勤務地
    東京都
  • 英語力
    上級

外資系大手製薬メーカーでの薬事/レギュラトリーインテリジェンスヘッドの募集です。ヘルスケア業界での薬事ご経験の方、ぜひご応募ください。

職務内容
【Role】
Provide leadership within our company, working collaboratively with both internal and external stakeholders, to advance Regulatory Science and strategically influence the policy environment set by regulatory authorities in JPAC region.
【Responsibility】
Guide development of policy positions for external influence and for internal product development (as needed). Cooperatively within Sanofi create and execute advocacy strategies to achieve policy goals.
・Develop effective and systematic approaches to bring functional excellence to Regulatory Policy across our group in JPAC with emphasis on key markets. Drive best practices and excellence in execution within the department and cross-functionally.
・Work closely and partner with a number of subject matter experts to plan regulatory advocacy positions, strategies and tactics and facilitate engagement with regulators on key topics of interest (influence regulatory authorities in the development and implementation of emerging regulatory policy).
・Proactively participate and track key developments from health authorities, trade associations, special interest groups, industry thought leaders and other external parties that are relevant to regulatory activities at Sanofi and industry at large. Communicate regarding specific regulatory trends, analysis, policies and Intelligence to different functions. Guide the strategy to understand and mitigate impact.
・Liaise closely with colleagues (R&D, External Affairs, etc.) leading policy activities in the external environment to ensure regulatory insights and overall alignment on our position.

・Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may bear influence to us and propose action plan.
応募条件
【Mandatory】
・Advance life science degree.
・+10 years experience in the field and/or related areas. Extensive and proven expertise in Regulatory environment in healthcare.
・Existing relationship with local/regional government legislators, committees, administrative staff or other key parties or influencers.
・Strong influencing and negotiation skills.
・English and Japanese: Fluent or Advanced Business Level
【Plus】
・Previous experience working with senior-level members or officials of trade associations or other key groups that influence regional policies.
・Experience in participating in, or supporting, global product development or other cross-functional teams.
・Outstanding interpersonal and communication/presentation skills.
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