【東京】Director, Regulatory Operation 
この求人にエントリーする
求人No. 178862
募集要項
業務内容 |
■Job Purpose ・Ensure mechanisms and organizational operations that enable the development and submission of regulatory submission documents in line with Japanese regulations and GSK rules and processes ・Lead and develop members (Japan Submission Managers) to be capable of leading, managing and producing required regulatory document submissions to contribute to achieving GSK’s regulatory milestones in collaboration with Global Regulatory Operation, Japan Development, and Japan Regulatory Affairs. ・Lead overall management and conflict management through overall development and submission of regulatory documents. ・Lead to the continuous improvement of productivity and simplification of regulatory documents and applications including cooperation with external vendors and utilization of digital technology ・Plan, implement, and maintain regulatory systems for efficient regulatory document development and submission through close communication with Global Regulatory Operation and R&D IT and other key stakeholders in digital. ■Key Responsibilities ・To set the department objectives aligned with divisional objectives and lead to achieve the objectives as the Regulatory Operation department. ・To continuously increase productivity and properly manage resources in the department. ・To lead and develop members (Japan Submission Managers) to be capable of leading, managing and producing required regulatory submissions to contribute to achieving GSK’s regulatory milestones in collaboration with Global Regulatory Operation, Japan Development, and Japan Regulatory Affairs. ・To collect relevant intelligence for maintaining internal processes to produce regulatory submissions of GSK Japan to be compliant with the local health authority’s requirements as well as GSK rule and internal processes. ・To facilitate preparation/submission of regulatory document submissions as part of Global and implement the latest technologies and digital tools that are considered necessary from business perspectives. ・When the global regulatory system is newly implemented and/or updated, local specific requirements to be adequately reflected into the system. ・To establish, operate, and maintain effective cooperative processes with external vendors to efficiently and flexibly carry out regulatory operation works. ・To understand and advise stakeholders, contract workers and others concerned locally and globally on Japan regulatory authority regulations and guidance associated with electronic submissions and gateway. ・To lead Japan Regulatory Affairs Division as the Japan Regulatory Affairs Leadership member |
|---|---|
語学力 |
要 ・Business level written and oral communication skills both in Japanese and English with ability to present information in a clear and concise manner. |
年収 |
1600万～1800万 |
給与 |
年俸制 賞与 年１回 |
雇用形態 |
正社員 |
勤務地 |
東京都 |
通勤交通費 |
全額支給 |
休日 |
年間休日122日 ■完全週休2日制（土日） ■祝日 ■年末年始 ■5月1日 ■四季休暇（5日） ■年次有給休暇（※勤続年数に応じて最高23日） ■積立年次有給休暇（※60日まで） ■特別有給休暇（リフレッシュ休暇、慶弔休暇、ドナー休暇など） ■出産休暇 |
福利厚生 |
■社会保険完備（雇用・労災・健康・厚生年金） ■従業員持株会 ■退職金制度 ■健康診断（定期健診、生活習慣病健診、人間ドックなど） ■育児休職制度 ■介護休職制度 ■在宅保育サービス割引制度 ■ACE Award制度（※会社業績アップに貢献した個人またはチームへの表彰制度） ■社内公募制度 ■各種研修（MR研修、管理職研修） ■自己啓発支援制度 |
この案件に似た求人もご紹介できます
企業情報
事業内容 |
医療用医薬品および一般医療関連製品の創造、発見、開発、製造および販売 |
|---|---|
業種分類 |
メディカル／医薬品メーカー |
この求人と似ている求人情報
あなたにぴったりの求人をご案内します
ここにメッセージが入る
コンサルタントから…
【東京】CMC薬事マネージャー／グローバルヘルスケアカンパニー