Manager, Regulatory Affairs

Beigene Com Cn

$121,500.00 - $161,500.00 annually; bonus/equity: ...
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Manage regulatory submissions
Clinical, non-clinical, and cmc
Fda and ich guidance
** Beigene Com Cn is seeking a Manager of Regulatory Affairs to oversee regulatory projects, ensuring compliance and timely submissions within a collaborative environment focused on cancer treatment. The ideal candidate will have over five years of experience in regulatory affairs, particularly with INDs and knowledge of FDA regulations. **

Job Summary

  • Manage, evaluate, and complete regulatory projects consistent with company goals, including timely planning and coordination of regulatory submissions.
  • Responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics.
  • BeOne is committed to fair and equitable compensation practices and offers a comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Matching Summary

Match Score: 75

** Beigene Com Cn is seeking a Manager of Regulatory Affairs to oversee regulatory projects, ensuring compliance and timely submissions within a collaborative environment focused on cancer treatment. The ideal candidate will have over five years of experience in regulatory affairs, particularly with INDs and knowledge of FDA regulations. **

Salary

$121,500.00 - $161,500.00 annually; Bonus/Equity: Eligible for annual bonus plan/discretionary equity awards/Employee Stock Purchase Plan; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness

Skills & Requirements

Must-have

  • manage regulatory submissions
  • clinical, non-clinical, and CMC
  • FDA and ICH guidance
  • GMP, GLP, and GCP regulations
  • pharmaceutical product life cycle

Nice-to-have

  • highly motivated, collaborative
  • passionate interest in fighting cancer
  • entrepreneurial, fast-paced environment
  • detail-oriented, self-starter
  • bold ingenuity, collaborative spirit

Key Requirements

  • 5+ years’ related experience
  • Bachelor's Degree
  • Experience with INDs
  • Experience with CTD/eCTD
  • Experience with Adobe Acrobat Professional

Work Rights

Not specified

Tailored Resume

Cover Letter