Program Manager - Regulatory Affairs Projects - Pharma - APAC

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 & 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 :

Required Qualifications :

(ref : iimjobs.com)