お仕事情報

お仕事情報

Regulatory Pharmaceutical Affairs Manager (Yakusei):SS-4437MY

  • 外資系企業
  • 女性が活躍
  • 管理職・マネジャー
  • 英語を活かす

米国カリフォルニア州に本社を置く世界最大の独立バイオテクノロジー企業

求人コード SS-4437MY
募集職種 Regulatory Pharmaceutical Affairs Manager (Yakusei)
職務内容 <Job Description>
Specialty:
・Management and Maintenance of business license activities
・Compliance review for documents and materials from regulatory perspectives
・Run a process of Package components’ artwork for Package Insert, Instruction for Use,
Package Labels/Materials through our system

<Job Summary>
・Conduct post marketing regulatory activities firmly and appropriately on a daily base to
manage and maintain pharmaceutical business activities
・Provide good and appropriate guidance and introduction to the relevant people and group from experiences and knowledge as well as the latest regulations and our policies.

<Key Activities>
・Regarding MAH, to have appropriate and close communication with Tokyo Metropolitan Government (TMG) for an arrangement related to a periodical inspection every 5 years and an irregular inspection, to submit change notifications within 30 days after the changes to TMG and to review GVP and GQP SOPs from the viewpoint of regulatory
・Regarding FMA, to apply and register new licenses and manage renewal of the licenses to MHLW/PMDA, to handle RTQ process appropriately and in a timely manner and to submit change notifications within 30 days after the changes to MHLW/PMDA
・Conduct 5 years periodic GMP inspections in collaboration with the Quality team
・Obtain import certificates (Yakkan) through NACCS system
・Submit export notifications for manufacturing and maintain appropriately and timely
・Run a process of Package components’ artwork for Package Insert, Instruction for Use,
Package Labels/Materials through our system (process management system) to meet the deadline under close communication with supply chain, QA, commercial & marketing and vendors, etc.
・Post a new or revised package insert on a PMDA web site on a fixed date.
・Conduct regulatory review of promotional and non-promotional materials for each drug product.
・Participate in working groups such as the Tokyo Pharmaceutical Manufacturers Association and engage in industry activities
応募要件 <Knowledge and Skills>
・J-NDA filing and registration skills of medicines in Japan
・Comprehensive and deep knowledge for Pharmaceuticals and Medical Device Laws
・Expertise for regulatory compliance as post marketing regulatory activities
・Working in matrix environments in Japan and global teams as the One Team
・Communication skills
・English conversation, read, and writing
・IT skills: Microsoft Outlook/ Word/ Excel/Power Point

<Education & Experience>
・Bachelor’s degree and at least 10 years of pharmaceutical industry experiences including at least 5 years in regulatory compliance activities such as business license management/maintenance and regulatory review for promotional and non-promotional
materials
勤務地 東京
年収 900万円~1300万円
最終学歴 大卒
推奨される資格要件 PhD、理系
その他

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