募集要項
- 募集背景
- 戦力強化のため。
- 仕事内容
-
高い成長を続けている外資系製薬会社で、Regulatory Affairs(薬事/TA Group)【シニアアソシエイト】を募集致します!免疫領域のご経験をお持ちの方歓迎。TA: Immunology
The Regulatory Affairs TA 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.
・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 regulatory 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
・Assist with major submissions to register NCEs or new indications for existing products when needed
・Educate and train regulatory strategy to the staffs
⇒続きは【キャリアパス・評価制度】の欄へ。
- 応募資格
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- 必須
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・Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical related fields is required
・More than 3 years related experience in regulatory affairs, including regulatory strategy and regulatory maintenance, from CTN submission to approval of the compounds.
・Must have pharmaceutical experience
・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
- 歓迎
- ・Experience in the area of immunology disease are preferable.
- フィットする人物像
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・Ability and desire to create results
・Excellent people skills and an upbeat and enthusiastic attitude.
- 雇用形態
- 正社員
- ポジション・役割
- レギュラトリーアフェアーズ(薬事)【シニアアソシエイト】
- 勤務地
- 東京本社
- 勤務時間
- 8:45~17:30
- 年収・給与
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600万円~800万円(目安)
【給与】 年 収:年俸制、昇給年1回 賞 与:年1回 手 当:住宅手当、通勤手当(全額)
- 待遇・福利厚生
- 各種社会保険等完備、退職金、団体生命保険、定期健康診断、自己啓発支援制度、社員持株会、財形貯蓄、医療費補助制度、永年勤続表彰制度、福利厚生プログラム、自動車通勤不可、TOEIC受験料補助
- 休日休暇
- 完全週休2日制、年間休日125日
- 選考プロセス
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【採用時期】ASAP(ご相談のうえで決定)
【選考プロセス】書類選考⇒面接(2回~3回)⇒内定
- キャリアパス・評価制度
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⇒続き
・Lead new product labeling development to archive target product profile and post marketing appropriate use
of the product. Maintain and revise current labeling timely and appropriately in accordance
with Global Company Core Data Sheet comply with regulatory requirements including GVP.
・Maintaining regulatory records for assigned product portfolio in compliance with local
and global procedures