Manager, Regulatory Affairs

BeOne Medicines Ltd

Base: $121,500.00 - $161,500.00 annually; bonus/eq...
Not specified
Manage regulatory submissions
Plan regulatory activities
Develop regulatory strategies
BeOne Medicines Ltd is seeking a Manager of Regulatory Affairs to oversee and manage regulatory submissions and strategy in a fast-paced environment focused on fighting cancer. The ideal candidate should have extensive experience in regulatory affairs, particularly in preparing 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.
  • The Manager will represent Regulatory Affairs on cross-functional project teams, will provide input to the project team, will lead authoring and preparation of annual reporting, and will manage regulatory submissions.
  • BeOne is committed to fair and equitable compensation practices, offering 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 Ltd is seeking a Manager of Regulatory Affairs to oversee and manage regulatory submissions and strategy in a fast-paced environment focused on fighting cancer. The ideal candidate should have extensive experience in regulatory affairs, particularly in preparing INDs, and possess strong communication and planning skills.

Salary

Base: $121,500.00 - $161,500.00 annually; Bonus/Equity: 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
  • Plan regulatory activities
  • Develop regulatory strategies
  • Ensure regulatory compliance
  • Prepare meeting requests and briefing documents
  • Maintain regulatory knowledge

Nice-to-have

  • Collaborative and passionate interest
  • Entrepreneurial, fast-paced environment
  • Scientific and business professionals
  • Fighting cancer

Key Requirements

  • 5+ years related experience
  • Bachelor's Degree
  • Experience with INDs
  • Experience with CTD/eCTD
  • Working knowledge of FDA and ICH
  • Working knowledge of GMP, GLP, GCP

Work Rights

Not specified

Tailored Resume

Cover Letter