RA Program Manager

About the job

Job Summary: We are seeking a highly experienced RA (Regulatory Affairs) 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 7 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 Escalation Regulatory 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. Required Qualifications: - Bachelor's degree in Life Sciences, Pharmacy, or a related field. - 7+ years in regulatory affairs project management in pharma industry (at least 3 years in RA projects with Japan-focused). - Familiarity with GVP/GMP/GCP, MHLW guidelines. - PMP or PRINCE2 certification is a plus. - Previous Smartsheet experience (3 years minimum) - Advanced degree (MS, PharmD, PhD) preferred.

Requirements

• regulatory affairs project management
• pharmaceutical industry
• Smartsheet experience

Qualifications

• Bachelor's degree in Life Sciences
• 7+ years in regulatory affairs project management

Preferred Technologies

• regulatory affairs project management
• pharmaceutical industry
• Smartsheet experience