Roche Job Posting: Quality and Regulatory Specialist
Company: Roche
Location: Singapore, Hong Kong, Philippines, China, Australia, Bangkok, India
Salary: Depends on Regions
Experience: 2 to 5 years
Qualification: B.Pharm, M.Pharm, Msc, BSc, M.tech
About Roche:
Roche fosters diversity, equity, and inclusion, representing the communities we serve. We believe that inclusion is key to understanding varied healthcare needs. Join Roche, where every voice matters.
Position Overview:
As a Quality and Regulatory Specialist at Roche, you will manage product launch projects, act as the RIMS Business Administrator, and support capacity building and meeting coordination. Additionally, you will manage the Q&R gSite and support strategic regulatory projects, including the Fusion Project Integration.
Key Responsibilities:
- Product Launch Projects:
- Coordinate launch planning and submission in APAC markets.
- Provide regulatory support and guidance to affiliates.
- Regulatory Information Management System (RIMS):
- Act as RIMS Business Administrator.
- Assist affiliates with data cleanup via automatic uploads.
- Develop submission folders to streamline submission management.
- Govern data in RIMS and provide registration activity overviews.
- Establish dashboards for management teams.
- Capacity Building and Meeting Coordination:
- Conduct training assessments.
- Plan and coordinate training initiatives.
- Evaluate training effectiveness.
- Coordinate meetings and events.
| Task | Description |
|---|---|
| Meeting Preparation | Plan and schedule meetings, book venues, arrange catering, and coordinate logistics. |
| Agendas and Materials | Prepare and distribute meeting agendas, materials, and presentations. |
| Equipment Setup | Ensure necessary equipment and technology are set up and functioning properly. |
| Attendance Management | Coordinate and confirm attendance, manage RSVPs, and send out reminders. |
| Meeting Minutes | Take accurate minutes and distribute them to attendees. |
| Documentation | Maintain an organized system for filing and archiving meeting documents. |
| Post-Meeting Reports | Prepare and distribute reports and action items. |
| Event Coordination | Collaborate with teams and vendors for successful event execution. |
| Process Improvement | Identify opportunities for process improvement and implement best practices. |
- Managing Q&R gSite and Supporting Strategic Regulatory Projects:
- Update APAC Q&R gSite for accuracy and functionality.
- Collaborate with cross-functional teams for content updates.
- Support regional operations and strategy.
- Supporting Fusion Project Integration:
- Prepare registration and notification listings.
- Integrate processes and databases for registration and quality management systems.
- Prepare documentation for license updates.
