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- Be part of one of the top global pharmaceutical companies in the industry
- Lead the RA team developing, manage, and executing of all regulatory documents
About Our Client
- One of the top global pharmaceutical companies in the industry
- Innovative and progressive products and therapies for unmet medical needs
- Rich pipeline within oncology, immunology, immuno-oncology, etc
- Customer and employee centric foundation that prides in high quality culture
Job Description
- Lead the RA team and be the representative of regulatory strategies
- Create Japan focused regulatory section in the submission planning, management, and execution for all regulatory documentation ex. PMDA consultation, CTN and CTD documents, etc.
- Review and provide regulatory input
- Manage CRO regulatory activities
- Review and consult appropriate regulatory promotion materials
The Successful Applicant
- At least 5 years experience in regulatory affairs in the pharmaceutical industry
- Experience in the development and management of regulatory strategies
- Collaboration with global stakeholders throughout development and submission
- High fluency in English and Japanese
What's on Offer
- Competitive salary and benefits
- Great work life balance
- International working environment
- Amazing career progression in regulatory affairs
- Work with key industry individuals solving unmet medical needs
Contact
Zach Itozu
Quote job ref
4210922
Phone number
+813 6832 8683
Job summary
Function
Specialisation
Industry
Location
Job Type
Consultant name
Zach Itozu
Consultant phone
+813 6832 8683
Job Reference
4210922
Company Type
