Sr RA Manager
開発薬事のSr Manager ポジション
Support Head ofSpecialty RA with the planning, management and execution of the Regulatory Affairs activities in Japan, includingPMDA consultation and J-NDA preparation and submission.
Acquire understanding of Global development plan and Global dossier content for assigned products, identify gaps and proposemitigations to complete Japanese filing.
Prepare and compile regulatory dossiers forPMDA consultation and J-NDA on track and filed in a timely manner.
Provide information on Japan-specific requirements to Global teams
Ensure submissions are in compliance withPMDA/MHLW current requirements.
Assess emerging issues and develop solutions to address them with members of management and stakeholders, together with Head ofSpecialty RA JP.
Cooperate with and support external development partners to ensure on-time completion of activities
Monitor, anticipate, collect and interpret regulatory issues and trends that will impact the development of products for the Japanese market, incl. policies and procedures, share this information with appropriate regional functions and assist in the development of strategies and plans of action to address them.
Participate in PMDA meetings/negotiations with PMDA, as required
At least 5 years of experience in RA for new drug development (not operational RA) in foreign based global pharmaceutical company
Proven working experience with foreign based global pharmaceutical companies in Japan is a mandatory
In depth understanding of latest Regulatory law/guideline/requirement in Japan
Understanding of Local regulatory environment and key initiatives
Proficient in written and spoken English
Salary ; 13M Japanese yen