Swiss multinational healthcare company.
Job Summary
The Regulatory Affairs Specialist will support major APAC Regulatory projects (e.g. the IVDR and RIMS project). He/she will help with the operational matters for the project management, including maintaining a variety of database and Dashboard, monitoring the project timelines & following up with stakeholders on action items. He/she will work closely with local, regional and the global stakeholders to provide technical support and insights.
Duties & responsibilities
- Support global/regional product launch projects, managing and coordinating launch planning & submissions in APAC markets, and providing countries with regulatory support and guidance
- Support the APAC countries with the Regulatory Information Management System (RIMS) and RIMS
- Support capacity building trainings
- Support of the Q&R Regional meeting
- Update of the Q&R G Site and support of Reg Operations and Strategy CoP and respective Squads
- Be the RIMS Business Administrator and work closely with countries and stakeholders to optimize the functions and processes to achieve submission excellence.
- Help countries to clean up their data via automatically uploads
- Develop submission folders to drive submission management (reduce double archiving of registration dossiers)
- Governance of Data in RIMS
- Provide overviews of registration activities in APAC and establish dashboard for countries for the management teams
- Provide registration status of projects to the region
- Engage affiliates in proper RIMS usage
- Administrative support of trainings
- Support other strategic regulatory projects as required by business
Requirements
- Education background in Data Science or Science will be preferred.
- At least 2 years of work experiences in IVD/Medical Device industry or healthcare sector will be preferred.
- Project Management experience is a plus.
- IT savvy and likes new tools.
- Good analytical skills with some business acumen.
- Strong communicator and collaborator.
- Able to proactively detect problems and come up with sound solutions, always deliver high standard of work with customer-centric mindset, and able make sound recommendations to all stakeholders.
- 6 months contract with extension
