募集要項
- 募集背景
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Overview:
Pipeline and On-Market Products Development and Maintenance from Regulatory perspectives
● Responsible and accountable for new product introduction and sustain product operation activity.
● Plan and execute necessary activities relating to medical devices and drugs.
● Manage regulatory activities relating to specific portfolio of products/projects
- 仕事内容
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Key Responsibilities:
Report to Head of QARA
Registration and maintenance of Medical Devices and Drug
● Develop and execute regulatory plans aligned with business strategy for complex projects including new products and maintenance of regulatory files for existing marketed products
● Identify & prioritize key areas of risk, and develop & implement appropriate mitigation plans
● Establish appropriate communication within RA, with global Marketing, and with other functions at project level and favor proactive communication
● Ensure Registration strategy and deliverables are aligned with project teams and business objectives
● Lead regulatory activities related to their portfolio of products
● Prepare, review, and approve labeling, J-CTD based on global dossier and in cooperation with PV/MDS and confirm sufficiency of total submission dossier package for approval
● Represent or lead the RA function on assigned cross-functional project teams
● May participate external advocacy activity and contribute internal environment improvement
● May provide direct supervision of individuals
● Monitor applicable regulatory documentation and propose solutions. Identify areas for improvement
● Develop and document sound regulatory decisions and justification
- 応募資格
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- 必須
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Skills & Experiences:
● Scientific (Chemical) or pharmaceutical background as well as regulatory knowledge (at least BA). Masters and/or PhD will be advantage.
● Experience of medical device registration (minimum 5 years).
● Experience of pharmaceutical drug filing (supportive activities would be acceptable).
● Management skills.
● Experience to prepare CTD Quality part (CMC RA)
● Demonstrated interpersonal skills including negotiation skills
● Ability to multitask and prioritize
● Establish relationship with regulatory authorities
● English skills: strong written, verbal communication and presentation skills (e.g., TOEIC: above 700 or 800)
● Experience worked for foreign companies is desirable
- 雇用形態
- Full-Time/正社員
- ポジション・役割
- Group Manager - Regulatory Affairs
- 勤務地
- Saitama Prefecture / Chiba Prefecture / Tokyo / Kanagawa Prefecture
- 年収・給与
- 11 million yen ~ 12.99 million yen