【COMPANY OVERVIEW】
Global Leader in Healthcare who have established a new pharmaceutical unit and looking for an RA Leader.
【JOB RESPONSIBILITIES】
You will be the national RA Lead in Japan reporting to the APAC RA Lead.
Develop regulatory strategies which meet business goal
Lead product registration and labelling revision
Lead PMDA meeting and CTN submission to perform clinical trial
Support Global R&D to develop Clinical Development Plan
Provide proactive regulatory advice and support to stakeholders
Monitor new RA requirements and proactively provide stakeholders with regulatory guidance
Establish effective communications and processes with stakeholders
Build effective working relationships with regulatory agency, industry associations and business partners
【REQUIREMENTS】
Minimum 5 years’ work experience for RA at pharmaceutical industry
Ability to communicate effectively in Japanese and English (both written and verbal)
Demonstrated ability to influence all levels of stakeholders at a multi-national organization
Demonstrated knowledge and experience for Japanese regulatory environment in pharmaceutical area
Demonstrated ability to work with cross-functional and cross-regional teams
Demonstrated problem-solving ability
【FOR FURTHER INFORMATION】
Click apply
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Contact Mark: