Regional Submission Planner

Location: Singapore Salary: competitive
Sector: Regulatory Affairs (RA) Type: Permanent

I am currently looking for a Regulatory Affairs Senior Specialist for a Global Pharma MNC client to join a dynamic Regulatory Team in Singapore.

Key responsibilities:

  • 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.

EA License No: 16S8216

Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)

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