募集要項
- 募集背景
- グローバルな研究開発型バイオ医薬品企業です。世界の最も複雑で深刻な疾患に対する先進的な治療薬を開発し市場に投入することで、長年にわたり培われた医薬品業界のリーダーとしての専門技術と能力をもとに、 最先端のバイオテクノロジーに対するフォーカスと情熱を注ぎます。 世界中で約28,000人の社員を擁し、170以上の国々において医薬品の販売を行います。
- 仕事内容
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The Regulatory Affairs Manager will be responsible for ensuring first time approval of new products and new indications for existing products through participation in local brand teams as well as educating to his or her staffs.
Major Responsibilities:
Develop local regulatory strategies and plan for major submissions to register New Chemical Entities (NCE) or new indications with Director of Regulatory Affairs and agree local submission timelines
Ensure Japan submission requirements are communicated to relevant regional and global support team
Determine local Regulatory Risk for submissions and risk mitigation strategies where relevant
Inform group manager of Regulatory Affairs and New Product Information (NPI) team of progress of applications and issues impacting local applications
- 応募資格
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- 必須
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Essential Skills & Abilities:
Ability and desire to create results
Requires excellent written and verbal communications in Japanese and business level communications in English
Ability to effectively work under tight deadlines and manage projects independently.
Resourcefulness in solving problems
Excellent people skills and an upbeat and enthusiastic attitude.
- 歓迎
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Education / Experience Required:
Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical related fields is required
More than 7 years related experience in regulatory affairs, including regulatory strategy and regulatory maintenance, from CTN submission to approval of the compounds. Experience in the area of infectious disease or autoimmune disease are preferable.
Must have pharmaceutical experience
- 雇用形態
- 正社員
- 勤務地
- 東京
- 年収・給与
- 900万円～1100万円（応相談）
