Manager, Regulatory Affairs

BeOne Medicines

Base: $121,500.00 - $161,500.00; bonus/equity: not...
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5+ years of regulatory experience
Ind and nda preparation
Knowledge of fda and ich regulations
** BeOne Medicines is seeking a Manager of Regulatory Affairs to oversee and facilitate regulatory projects aligned with the company's mission of combating cancer. The ideal candidate will have extensive experience in regulatory submissions and knowledge of FDA and ICH guidelines, working in a collaborative and fast-paced environment. **

Job Summary

  • BeOne is seeking an experienced and energetic person to manage regulatory projects consistent with company goals.
  • The Manager will represent Regulatory Affairs on cross-functional project teams and lead authoring of regulatory submissions.
  • BeOne offers a comprehensive benefits package including medical, dental, vision, and 401(k).

Matching Summary

Match Score: 75

** BeOne Medicines is seeking a Manager of Regulatory Affairs to oversee and facilitate regulatory projects aligned with the company's mission of combating cancer. The ideal candidate will have extensive experience in regulatory submissions and knowledge of FDA and ICH guidelines, working in a collaborative and fast-paced environment. **

Salary

Base: $121,500.00 - $161,500.00; Bonus/Equity: Not specified; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • 5+ years of regulatory experience
  • IND and NDA preparation
  • Knowledge of FDA and ICH regulations

Nice-to-have

  • Experience with global regulatory requirements
  • Strong oral and written communication skills
  • Detail-oriented and self-starter

Key Requirements

  • Bachelor's Degree required
  • Experience with CTD/eCTD
  • Understanding of GMP, GLP, and GCP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter