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Location
ボストン
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-17904-3
Contact
Yin Yin Pui
Contact email
Email Yin
Contact phone
+65 6692 0751
Posted
約1ヶ月前
The Role:

  • Drive regulatory strategies for current corporate portfolio and ensure alignment to regulatory goals with business objectives through cross-functional collaboration (e.g. R&D, Clinical, Quality, and Commercial teams)
  • Ensure successful submissions by overseeing accurate document preparation and interactions with health authorities; and represent company interests in regulatory agency interactions
  • Stay current on regulatory trends, share insights for informed decisions.
  • Conduct internal regulatory training as required, represent company as expert in industry forums, and lead regulatory team growth for peak performance.


Qualifications:

  • Relevant degree with 5+ years regulatory affairs experience within the biopharma industry, with track record in successful regulatory submissions and approval
  • Strong knowledge of global regulatory guidelines (FDA, EMA, etc.) and regulations
  • Previous experience in handling Oncology or related projects a plus.
  • Experience in AI-driven drug discovery or biotech is advantageous



BeathChapman Pte Ltd