Manager, Regulatory Affairs

Beonemedicines Com Br

Base: $121,500.00 - $161,500.00 annually; bonus/eq...
Not specified
Manage regulatory submissions
Regulatory strategy and tactics
Inds and amendments
BeOne Medicines is seeking a Manager of Regulatory Affairs to oversee regulatory projects and submissions, particularly related to cancer-fighting pharmaceuticals. The ideal candidate will have significant experience in regulatory affairs, particularly with INDs, and possess strong communication and planning skills

Job Summary

  • BeOne is seeking an experienced and energetic person to manage, evaluate, and complete regulatory projects consistent with company goals.
  • This individual will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics.
  • The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Matching Summary

Match Score: 85

BeOne Medicines is seeking a Manager of Regulatory Affairs to oversee regulatory projects and submissions, particularly related to cancer-fighting pharmaceuticals. The ideal candidate will have significant experience in regulatory affairs, particularly with INDs, and possess strong communication and planning skills.

Salary

Base: $121,500.00 - $161,500.00 annually; Bonus/Equity: eligible for annual bonus plan and equity awards; Benefits: comprehensive benefits package

Skills & Requirements

Must-have

  • manage regulatory submissions
  • regulatory strategy and tactics
  • INDs and amendments
  • FDA and ICH guidance
  • GMP, GLP, and GCP regulations

Nice-to-have

  • scientific and business professionals
  • collaborative
  • passionate interest in fighting cancer
  • entrepreneurial, fast-paced environment
  • detail-oriented

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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