Manager, Regulatory Affairs

Beonemedicines Com Au

Base: $121,500.00 - $161,500.00 annually; bonus/eq...
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Manage regulatory submissions
Regulatory strategy and tactics
Fda and ich regulatory guidance
** BeOne Medicines is seeking a Manager of Regulatory Affairs with a strong background in regulatory submissions, particularly INDs and NDAs, to contribute to their mission of developing affordable cancer treatments. The ideal candidate should possess at least five years of relevant experience, excellent communication skills, and familiarity with regulatory guidelines across various regions. **

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: 75

** BeOne Medicines is seeking a Manager of Regulatory Affairs with a strong background in regulatory submissions, particularly INDs and NDAs, to contribute to their mission of developing affordable cancer treatments. The ideal candidate should possess at least five years of relevant experience, excellent communication skills, and familiarity with regulatory guidelines across various regions. **

Salary

Base: $121,500.00 - $161,500.00 annually; Bonus/Equity: eligible for annual bonus plan and equity awards; Benefits: comprehensive benefits package

Skills & Requirements

Must-have

  • manage regulatory submissions
  • regulatory strategy and tactics
  • FDA and ICH regulatory guidance
  • pharmaceutical product life cycle
  • prepare regulatory dossiers

Nice-to-have

  • entrepreneurial, fast-paced environment
  • collaborative and passionate interest
  • 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 GMP, GLP, GCP

Work Rights

Not specified

Tailored Resume

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