レギュラトリーアフェアーズ（薬事）【シニアアソシエイト】の転職・求人情報 25558095

募集要項

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

必須: ・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

フィットする人物像: ・Ability and desire to create results
・Excellent people skills and an upbeat and enthusiastic attitude.

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

キャリアパス・評価制度: ⇒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

事業内容・会社の特長: 医療用医薬品の研究、開発、製造、輸出入、販売
【主要領域】肝疾患、神経疾患、自己免疫疾患、オンコロジー、腎疾患、ウィメンズヘルス

当社のミッションは現在の深刻な健康課題を解決する革新的な医薬品の創製と提供、そして未来に向けて医療上の困難な課題に挑むことです。患者さん一人ひとりの人生を豊かなものにするため次の主要領域に取り組んでいます。免疫疾患、がん、神経疾患、アイケア、ウイルス、ウイメンズヘルス、消化器疾患、さらにエステティクスポートフォリオの製品・サービスです。