I am currently looking for a Regulatory Affairs Senior Specialist for a Global Pharma MNC client to join a dynamic Regulatory Team in Singapore.
- Coordinating of regulatory change assessments from local countries within the region and documentation within the CMC change management electronic systems
- Prioritising of execution of submissions as per global regulatory strategy and in coordination with local affiliates to ensure regulatory conformance
- To represent the regional CMC strategy across different functional teams to understand local/regional CMC requirements, maintain close communication with regional and local affiliates
- Prepare submission documentation by modifying and consolidating global documents for local submissions according to local/regional requirements, and consult with subject matter experts in global CMC and local countries.
The successful candidate should possess:
- Strong project management - Strong RA experience - Good communication skills - Experience with managing dossiers
- Strong RA experience
- Excellent communication skills
- Good knowledge and experience with managing dossiers
If you meet the essential requirements for this position, please send your latest CV through the link provided , or call Vanessa Tan at +65 6871 4700 for further information.
Only shortlisted candidates will be notified via email.
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