Key Responsibilities:
Product Launch Projects
- Manage and coordinate launch planning and submission in APAC markets, providing affiliates with regulatory support and guidance.
Regulatory Information Management System (RIMS)
- Act as the RIMS Business Administrator, working closely with affiliates and stakeholders to achieve submission excellence.
- Assist affiliates in cleaning up their data via automatic uploads.
- Develop submission folders to drive submission management and reduce double archiving of registration dossiers.
- Govern data in RIMS and provide overviews of registration activities in APAC.
- Establish dashboards for countries for management teams and provide registration status of projects to the region.
- Engage affiliates in using RIMS and provide administrative support for trainings.
Capacity Building and Meeting Coordination
- Conduct assessments to identify gaps and training requirements.
- Collaborate with internal and external stakeholders to plan and coordinate administrative and logistical aspects of training initiatives.
- Evaluate the effectiveness of training initiatives.
- Coordinate all aspects of meetings/conferences and events, ensuring smooth and efficient execution.
- Assist in planning and scheduling meetings, booking venues, arranging catering, and coordinating logistics.
- Prepare and distribute meeting agendas, materials, and presentations in a timely manner.
- Ensure necessary equipment and technology are set up and functioning properly for meetings.
- Coordinate and confirm attendance of participants, manage RSVPs, and send out meeting reminders.
- Take accurate meeting minutes and distribute them to attendees in a timely manner.
- Maintain an organized system for filing and archiving meeting-related documents and materials.
- Assist in preparing and distributing post-meeting reports and action items.
- Act as a point of contact for meeting-related inquiries and provide support to meeting participants as needed.
- Collaborate with internal teams and external vendors to ensure successful event coordination.
- Stay updated with relevant tools and technologies for efficient meeting management.
- Continuously identify opportunities for process improvement and implement best practices.
Managing Q&R gSite and Supporting Strategic Regulatory Projects
- Update APAC Q&R gSite, ensuring accuracy, functionality, and a positive user experience.
- Collaborate with cross-functional teams to gather and update gSite content.
- Support regional operations and strategy community of practice and respective squads.
Supporting Fusion Project Integration
- Prepare registration and notification listing.
- Integrate processes and database for registration and quality management systems.
- Prepare documentation for license updates.
