My client is a global, research and development-driven pharmaceutical company headquartered in Osaka.
- Role: RA Manager - Oncology
Location: Tokyo & Osaka
Requirements:
- Business level Japanese, English TOEIC 730
- 3-5years experience in RA
- Oncology experience or can be from PMDA/FDA
- No people management
- Role: Regulatory Affairs Director - Oncology
Location: Tokyo & Osaka
Requirements:
- Business level Japanese, English TOEIC 730
- 5-10 years of experience in RA
- Oncology experience or can be from PMDA/FDA
Responsibilities:
- No people management required
- Leads the regulatory working team for Japan, represents as needed at project team, and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan - or oversees if delegated and/or vendor.
- Partner with the Japanese market access and understand market access and reimbursement topics and support opportunities to drive consolidated inputs into Japanese product development plans.
- Accountable for working with other RA functions(CMC, Operations) and/or vendors to ensure that regulatory submissions and approvals are achieved on schedule within Japanese responsibility.
- Role: Regulatory Manager/ Director - Neuroscience + Marketed Products
Location: Osaka Only
Requirements:
- Business level Japanese, English TOEIC 730
- 3-5yrs experience for the manager, 5-10yrs experience for the Director
- Experienced in new drug development and regulatory affairs
- Those who have experience of applying for 3 poles at the same time are welcome
- We welcome those who have experience coordinating with the Global Team regarding package inserts.
- Those who can formulate strategies for products whose development phase is shallow are welcome.
- We welcome those who are able to develop countermeasures and strategies for post-marketing items.
Responsibilities:
- Leads the regulatory working team for Japan, represents as needed at project team, and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan - or oversees if delegated and/ or vendor.
- Partner with the Japanese market access and understand market access and reimbursement topics and support opportunities to drive consolidated inputs into Japanese product development plans.
- For the project(s)/product(s) of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning.
- Role: Regulatory Affairs Director
Locations: Osaka, consider Tokyo
Requirements:
- Business level Japanese, English TOEIC 730
- Experience in new drug development and regulatory affairs (10 years or more)
- Those who can plan strategies for products in the early to late development phases
- Those who have experience in global simultaneous development and application for approval
Responsibilities:
- In assigned projects, perform the following roles in collaboration with Japan Regulatory Leads in Therapeutic Area Regulatory Affairs from simultaneous development and submission viewpoints:
a) Regulatory Input (Including strategy planning) to Japan Development Team, Global Project Team, and Global Regulatory Team during the development phase
b) NDA filing and obtaining approval (Including strategy planning)
c) Regulatory Communications
d) Regulatory compliance
- Collaborate and build relationships with internal functions (team leaders, division heads, etc.), and regulatory authorities(PMDA reviewers, auditors, etc.). in assigned projects (or disease area, etc.)
- Role: Regulatory Affairs Dept, GI Group Manager
Location: Osaka
Requirements:
- Business level Japanese, English TOEIC 730
- 7 years of experience related to clinical development of new drugs, or 5 years of experience in the development of regulatory affairs
- Ability to plan strategies for products in early to late development phases
Responsibilities:
- Collaborates to define, develop and lead Japan's regional strategies to maximize regulatory and patient access to enable patient access to meaningful medicines in alignment with program objectives.
- Create and execute Japan regulatory strategies (about regulatory communication, NDA filing and obtaining approval, package insert creation and change, etc) of the assigned project(s).
- Effectively communicates objective assessments of the likelihood of success of these regulatory strategies. Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements.
For further information about this position please apply.
