|部署・役職名||R＆D Regulatory Affairs Manager － Specialty care|
Roles & Responsibilities
The R&D Regulatory Affairs has responsibility for managing products under development and/or marketed products with new indications/dosages.
· Develop regulatory strategy for new drug developments, Health Authority meetings and Japan New Drug Submission (J-NDA) and provide regulatory expertise within project/product teams for products under development and/or marketed products,
· Prepare Japanese Common Technical Documents (J-CTD) for the regulatory submission and arrange the internal review of J-CTD,
· Define, Coordinate and contribute to the preparation of Clinical Trial Notification (CTN), Health Authority meetings (e.g. PMDA Consultation Meetings) and major regulatory submission (e.g. J-NDA and J-sNDA) and/or any type of responses document to Health Authority questions with the stakeholders (Non clinical, clinical, Medical, Pharmacovigilance, etc.),
· Ensure maintenance and compliance of regulatory activities for development and marketed products,
· Be a communication hub between Australia/South Korea and Global as the JPAC representative,
· Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.
· Coordinate Japanese Package Insert Revision activities on Commercial and Medical Division’s request that is covered by PMDA New Drug Review Division.
【必須（MUST）】Knowledge And Skills:
Leadership skill with Play to win behaviors
· Strategy focus and clear/courageous mindset
· Mutual respect by the open communication and well-stakeholder management
· Knowledge /experience of regulatory submission and approval.
· Experience of people leader (including coaching/mentoring) and great passion for the people development
· Respect others with DE&I mindset
· English communication skill
Formal Education And/Or Experience Required:
· Bachelorship of pharmaceuticals or science
· Experience of regulatory activities, including interaction with PMDA/MHLW in RA organization
【歓迎（WANT）】Knowledge And Skills Desirable But Not Essential:
· Knowledge about the recent regulation
· Oncology regulatory experience and knowledge
· Network in the Regulatory field/Pharmaceutical industries
|アピールポイント||自社サービス・製品あり 外資系企業 女性管理職実績あり 従業員数1000人以上 シェアトップクラス 年間休日120日以上 産休・育休取得実績あり 教育・研修制度充実|