Manager, Regulatory Affairs

beigene.ae

$121,500.00 - $161,500.00 annually; bonus/equity: ...
Not specified
Manage regulatory submissions
Plan regulatory activities
Inds and amendments
BeOne is seeking a Manager of Regulatory Affairs with over five years of experience in regulatory submissions, particularly INDs, within a collaborative and fast-paced environment focused on oncology. The ideal candidate should possess strong communication skills, attention to detail, and a comprehensive understanding of regulatory requirements

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 is seeking a Manager of Regulatory Affairs with over five years of experience in regulatory submissions, particularly INDs, within a collaborative and fast-paced environment focused on oncology. The ideal candidate should possess strong communication skills, attention to detail, and a comprehensive understanding of regulatory requirements.

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
  • INDs and amendments
  • FDA and ICH guidance
  • Pharmaceutical product life cycle

Nice-to-have

  • Scientific and business professionals
  • Highly motivated, collaborative
  • Passionate interest in fighting cancer
  • Entrepreneurial, fast-paced environment
  • Detail-oriented, self-starter

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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