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Job Details

Location
Boston
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-173912
Contact
Tom Tan
Contact email
Email Tom
Posted
about 1 month ago
The Company

They initially incorporated in Singapore where will be their manufacturing capability for global commercialising purposes.  Their senior leadership team sits in Boston office whilst their Shanghai team has a wider range of functions and sites, including CMC plant, corporate office & laboratory center.  They focus on mRNA technology that dedicates to vaccines (Covid-19 vaccine to start with), oncology, immunology and so forth with further growth plan. 
 
The Job
  • Manage early regulatory affairs from discovery stage to BLA filing, by working closely with their research team and management team
  • You will manage not only U.S domestic market submission and filing but also Europe & Australia
  • Practical knowledge on regulatory strategics and tactics for dealing with local authorities including but not limited to FDA, EMA & TGA
  • Report to Regulatory Affairs Head
The Requirements
  • Bachelor degree with at least 10 year work experience on regulatory and latest years on non-clinical stage
  • FDA, EMA or/and TGA exposure
  • Interpersonal, results-driven and team player
 
You will be offered competitive package with full benefits, including 401(k), medical insurance, paid leave, sick leave, dental and vision care.


Reg No. R1109268
BeathChapman Pte Ltd
Licence no. 16S8112