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Senior Regulatory Affairs Manager

Publication date 2021/10/25

Work Location , Expected annual income :

Tokyo,10.0M ~ 13.0M

About Company :

Global Rare Diseased focused Pharmaceutical Company

Responsibility :

You will be responsible for:
- Provide strategic Japanese and Asian regulatory leadership to project teams in early and late stage clinical development.
- Identify potential regulatory risks to the strategic / operational plans and propose options to mitigate risks.
- Lead the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle from Japan and Asia regional perspective. This will include clinical trial applications, pediatric investigation plans, briefing documents and NDAs and/or MAAs.
- Manage relationships with CROs and Regulatory Affairs consultancies to ensure business objectives are met.
- Contribute to the preparation of new regulatory guidance and communicate the impact of new regulatory requirements across the organization.

Benefits :

- Social insurance
- Pension plan

Required Experience / Abilities / Skills :

Minimum Requirement for this role is:
- Has strong blend of being a team player, but also able to work on own initiative and prepared to take ownership and responsibility for his/her actions.
- University Degree in Science or related discipline. A higher degree would be desirable.
- At least ten years of experience of working in one or more areas in Regulatory Affairs in the pharmaceutical or related industry, or experience at a health authority.
- Ideally a combined mix of large company best practices and smaller company adaptability and experience.

Please contact to :

Akihisa Hirota
Healthcare Team
* Please note only qualified candidate will be contacted.

JOB ID : IJB2001039

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