Manager, Regulatory Affairs

beigene.jp

Base: $121,500.00 - $161,500.00 annually; bonus/eq...
Not specified
Manage regulatory submissions
Regulatory strategy and tactics
Planning and coordination of regulatory submissions
Beigene.jp is seeking a Manager in Regulatory Affairs to oversee and coordinate regulatory submissions and strategies for their oncology products. The ideal candidate should have a strong background in regulatory processes, particularly with INDs and NDAs, and possess excellent communication and organizational skills

Job Summary

  • BeOne is seeking an experienced and energetic person to manage, evaluate, and complete regulatory projects consistent with company goals.
  • This individual will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics.
  • 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

Beigene.jp is seeking a Manager in Regulatory Affairs to oversee and coordinate regulatory submissions and strategies for their oncology products. The ideal candidate should have a strong background in regulatory processes, particularly with INDs and NDAs, and possess excellent communication and organizational skills.

Salary

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

Skills & Requirements

Must-have

  • manage regulatory submissions
  • regulatory strategy and tactics
  • planning and coordination of regulatory submissions
  • INDs and amendments
  • BLAs/NDAs and supplements
  • FDA and ICH regulatory guidance

Nice-to-have

  • scientific and business professionals
  • highly motivated, collaborative
  • passionate interest in fighting cancer
  • entrepreneurial, fast-paced environment
  • collaborative spirit

Key Requirements

  • 5+ years related experience with Bachelor's Degree
  • Experience with INDs
  • Experience with CTD/eCTD
  • Experience with Adobe Acrobat Professional
  • Knowledge of GMP, GLP, GCP regulations

Work Rights

Not specified

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