Regulatory Affairs Manager

Manager Regulatory Affairs

Location: Tokyo

ICON are currently looking for a Manager Regulatory affairs to join the Global Regulatory Affairs consulting team. Based at offices in Tokyo, you will be working with a team of Regulatory professionals who provide strategic and operational expertise to clinical trials, to drug development and to MAA/ NDA programmes.   Forming part of a successful and driven team, you will act as Regulatory Project Lead in providing consultancy for ICON global projects, dealing directly with clients and Regulatory Agencies.  ICON Regulatory Affairs projects cover all aspects of drug development and all areas of development

Role Summary

• A Regulatory professional who contributes to drug development, as part of the Regulatory Affairs team, through provision of regulatory guidance and operational support to early drug development, agency interactions, clinical trial applications, marketing applications and post approval support
• Manager Regulatory Affairs is a Regulatory professional who will have prior experience with several areas of Regulatory affairs (CTA/IND/MAA) and the ability to lead internal teams and carry out regulatory activities and submissions independently
• May work as part of a regulatory or cross-functional team depending on the size and nature of project
• Contributes to ICON Regulatory Affairs through their understanding of Regulatory process and interpretation of guidelines to develop best practices

Experience and Qualification

A University degree in medicine, science, or equivalent is required. In addition, you will also require:

• Excellent communication and interpersonal skills, both written and verbal in local language with desirable experience in business English language
• A minimum of five years’ experience in the pharmaceutical or pharmaceutical contract service industry within Regulatory Affairs in a similar role
• Ability to produce accurate work to tight deadlines within a pressurised environment
• Ability to work both independently and in a team environment
• Proficiency with computer systems

You will have the opportunity to be exposed to a number of diverse projects and clients and to progress your career into management or into other related areas where you can further develop your skill set.