Senior Associate, Regulatory Affairs (us)

Beonemedicines Com Cn

Base: $40.91 - $52.91 ph; bonus/equity: annual bon...
Hands-on u.s. ind preparation experience
Nda and bla submission support
Fda regulatory compliance knowledge
The role involves planning, tracking, and executing U.S. regulatory submissions to the FDA for investigational and commercial products

Job Summary

  • The role involves planning, tracking, and executing U.S. regulatory submissions to the FDA for investigational and commercial products.
  • Candidates must possess prior Regulatory Affairs experience with hands-on support of U.S. IND preparation as this is not an entry-level position.
  • BeOne Medicines offers a comprehensive benefits package including medical, dental, vision, 401(k), and discretionary equity awards.

Matching Summary

The role involves planning, tracking, and executing U.S. regulatory submissions to the FDA for investigational and commercial products.

Salary

Base: $40.91 - $52.91 per hour; Bonus/Equity: Annual bonus plan eligible; Equity: Discretionary stock awards available

Skills & Requirements

Must-have

  • Hands-on U.S. IND preparation experience
  • NDA and BLA submission support
  • FDA regulatory compliance knowledge
  • eCTD technical specifications proficiency
  • Cross-functional coordination skills

Nice-to-have

  • Veeva Vault RIM system familiarity
  • Adobe Acrobat Professional publishing skills
  • ICH regulatory guidance understanding
  • Continuous learning mindset
  • Entrepreneurial approach to work

Key Requirements

  • BA/BS degree in scientific or health-related discipline
  • 3+ years of Regulatory Affairs experience
  • Experience with CTD/eCTD document assembly
  • Proficiency in Microsoft Office and regulatory tracking tools

Work Rights

Not specified

Tailored Resume

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