Manager, Regulatory Affairs

beigene.se

Base: $121,500.00 - $161,500.00 annually; bonus/eq...
Not specified
Manage regulatory submissions
Plan regulatory activities
Regulatory strategy and tactics
BeOne is seeking a Manager of Regulatory Affairs with over five years of experience to oversee regulatory projects and submissions related to drugs and biologics. The ideal candidate will possess a strong background in regulatory processes, particularly with INDs and NDAs, and will thrive in a collaborative and fast-paced environment focused on cancer treatment

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 to oversee regulatory projects and submissions related to drugs and biologics. The ideal candidate will possess a strong background in regulatory processes, particularly with INDs and NDAs, and will thrive in a collaborative and fast-paced environment focused on cancer treatment.

Salary

Base: $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 preparation
  • FDA and ICH regulatory guidance
  • GMP, GLP, and GCP regulations

Nice-to-have

  • Collaborative and passionate interest
  • Entrepreneurial, fast-paced environment
  • Scientific and business professionals
  • Continuous learning and embracing change

Key Requirements

  • 5+ years related experience
  • Bachelor's Degree
  • Experience with INDs
  • Experience with CTD/eCTD
  • Experience publishing in Adobe Acrobat
  • Knowledge of other regions desirable

Work Rights

Not specified

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