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 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.