Manager, Regulatory Affairs

Beonemedicines

$121,500.00 - $161,500.00 annually; bonus/equity: ...
Not specified (assumed to be hybrid based on the industry norms).
Manage regulatory submissions
Plan regulatory activities
Regulatory strategy and tactics
BeOne Medicines is seeking a Manager of Regulatory Affairs to oversee and coordinate regulatory submissions and projects, with a focus on fighting cancer. The ideal candidate will have over five years of experience in regulatory affairs, particularly with INDs and NDAs, and will thrive in a collaborative, fast-paced environment

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.
  • 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 and coordinate regulatory submissions and projects, with a focus on fighting cancer. The ideal candidate will have over five years of experience in regulatory affairs, particularly with INDs and NDAs, and will thrive in a collaborative, fast-paced environment.

Salary

$121,500.00 - $161,500.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • Manage regulatory submissions
  • Plan regulatory activities
  • Regulatory strategy and tactics
  • INDs and amendments
  • FDA and ICH regulatory guidance

Nice-to-have

  • Fighting cancer
  • Entrepreneurial, fast-paced environment
  • Collaborative
  • Highly motivated
  • Passionate interest

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter