RA Manager ~Senior Manager (Start-up Pharmaceutical Business Unit)

Location Tokyo
Job type Permanent
Salary 11,000,000 - 14,000,000 JPY
Reference 33008

【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

OR

  • Contact Mark:

mark.griffin@cornerstone.jp