Job Description

Job Summary:We are seeking a highly experienced RA Program Manager to lead the planning, coordination, and execution of regulatory affairs projects in APAC (including Japan). The ideal candidate will have in-depth experience with RA Program management within pharmaceutical industry, should have at least 6 years of experience in RA programs or projects management for Japan, a good understanding of RA requirements for NDA preparation and submission to PMDA, good understanding of MAH responsibilities, and post-marketing RA lifecycle management. The program manager will be the liaison between the client and cross-functional team and will ensure that all deliverables are prepared and completed according to the approved timelines.Key Responsibilities:Program & Project Management:- Lead end-to-end RA projects and programs from planning phase, through execution phase till closure.- Serve as the primary contact for Japan-related regulatory projects with GRP senior management and client.- Develop project plans, project trackers of deliverables, risk mitigation strategies, and timelines for each project .- Schedule weekly or biweekly meeting with clients to give them projects updates.- Prepare meeting presentations and meeting minutes for every meeting with client- Track and monitor the completion of deliverables and pending actions with both client and GRP project's team.- Maintain documentation: Gantt charts, project trackers, weekly reports and timesheets for project members.- Track and Maintain KPIs for each projects including GRP members KPIs - Maintain Project deadline- Must have experience and good understanding of using smartsheet in project management .- Shall generate monthly reports on status of each project using smartsheet. - Shall generate monthly timesheets for all project members using smartsheet- Lead Communication with all stakeholders- Manage Disaster EscalationRegulatory Affairs Support:- Coordinate regulatory submissions: J-NDA, variations, MAH transfers, etc.- Support CTD module preparation, document QC, and regulatory review.- Monitor Japan regulatory landscape (PMDA, MHLW) and ensure compliance.- Align local project strategies with global regulatory goals. (ref:biojoby.com)