Summary

Contribute to the overall activities in drug development toward obtaining the marketing authorization and maintenance activities of post marketing products in assigned TA area.
Drug development including development of drug, medical device, companion diagnostics and tissue-engineered medical products

About the Role

Major accountabilities:

• Assist developing innovative and high quality regulatory strategies to facilitate regulatory processes in development and ensure registration with optimized labels that contribute to health and welfare of the Japanese nation.
• Contribute to the regulatory activities in day-to-day operations for assigned TA area.
• Lead cross functional communication for preparing and finalizing Japanese labeling for new drugs.
• Lead regulatory related actions to maintain post marketing products in Japan.
• Establish strong relationship with the Japanese HA and obtaining high credibility in responsible projects.
• Ensure adherence to regulations, guidelines and global/internal procedures as required.
• Represent RA within specific internal discussions across line functions and external industry meetings.
• Mentor RA associates on drug development.
• Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
• 100% timely delivery of all training requirements including compliance.

• Achieve planned submission and approval in time in responsible projects.
• Obtain preferable outcomes of PMDA consultation in development phase projects for which the GPRM-J is responsible.
• No critical problem for maintaining post marketing product in responsible projects.
• Fulfil regulatory responsibilities in Japan to the GPT/GBT and RA subteam, and achieve registration with the best possible labeling.

• Train and mentor RA members concerning drug development.
• Understand varied knowledge of Japan regulation.
• Possess extensive knowledge of MHLW/PMDA management, structures and organizations, and maintain trustful working relationship with MHLW/PMDA.
• Contribute to discussions on licensing conditions and integrate legal considerations into regulatory strategy.
• Possess extensive scientific knowledge of assigned TA/disease area, and facilitate scientific interactions between experts relevant for drug development/maintenance.
• Address scientific issues across line functions and implement action plans.
• Define internal procedures for complying with effective regulatory requirements and enhancing quality and efficiency of the processes.
• Effectively negotiate with cross functional teams and lead an agreement in the optimal solution, and manage internal/external negotiation on development strategies and business critical issues.
• Excellent in effectively making presentation to clarify discussion items and raise key points to focus on in English.
• Contribute drug development planning by integrating expertise in the regulatory, legal and business environments.
• Possess extensive knowledge of global regulatory environment, and take appropriate actions to resolve issues identified in the projects that may negatively affect development strategy and progress.

• Degree in pharmacy, medicines, science, agriculture and/or pharmaceutical engineering discipline required. Advanced degree (Master Degree, PhD, etc.) preferred.
• Pharmacist license preferred.

• Fluent English as business language.