Associate Manager, Regulatory Affairs

BeiGene

Base: $103,000.00 - $138,000.00 annually; bonus/eq...
4+ years pharmaceutical industry experience
Regulatory submission preparation and assembly
Ind bla nda supplement management
The role involves managing, evaluating, and completing regulatory projects consistent with company goals while providing guidance on regulatory strategy

Job Summary

  • The role involves managing, evaluating, and completing regulatory projects consistent with company goals while providing guidance on regulatory strategy.
  • Candidates must be responsible for the timely planning, coordination, and submission of regulatory dossiers including INDs, BLAs, NDAs, and annual reports.
  • BeOne offers a comprehensive benefits package including medical, dental, vision, 401(k), paid time off, and opportunities for equity awards.

Matching Summary

The role involves managing, evaluating, and completing regulatory projects consistent with company goals while providing guidance on regulatory strategy.

Salary

Base: $103,000.00 - $138,000.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, Wellness

Skills & Requirements

Must-have

  • 4+ years pharmaceutical industry experience
  • Regulatory submission preparation and assembly
  • IND BLA NDA supplement management
  • Cross-functional team collaboration
  • Regulatory archive maintenance

Nice-to-have

  • Scientific and business professional background
  • Passionate interest in fighting cancer
  • Experience with external consultants and CROs
  • Ability to work with minimal supervision

Key Requirements

  • BA/BS in Health Science
  • 4+ years experience in pharmaceutical industry

Work Rights

Not specified

Tailored Resume

Cover Letter