Global Regulatory Lead

165

Base: $111,000 - $160,333.33; bonus/equity: not sp...
Hybrid
3-5 years regulatory experience
Nda and ind submission preparation
Medical device regulatory knowledge
This role supports the development and execution of regulatory strategies for drugs, medical devices, and combination products to bring them to market

Job Summary

  • This role supports the development and execution of regulatory strategies for drugs, medical devices, and combination products to bring them to market.
  • The successful candidate will lead regulatory submissions such as NDAs and INDs while coordinating with publishing teams and participating in FDA meetings.
  • Opella is a global self-care challenger with over 100 brands and a mission to make health simpler and more human for half a billion consumers.

Matching Summary

This role supports the development and execution of regulatory strategies for drugs, medical devices, and combination products to bring them to market.

Salary

Base: $111,000 - $160,333.33; Bonus/Equity: Not specified; Benefits: Eligible for company employee benefit programs

Skills & Requirements

Must-have

  • 3-5 years regulatory experience
  • NDA and IND submission preparation
  • Medical device regulatory knowledge
  • FDA agency meeting participation
  • Product labeling compliance review

Nice-to-have

  • Cross-functional team collaboration
  • Competitor approval monitoring
  • Scientific input provision
  • Global regulatory affairs initiatives

Key Requirements

  • Bachelor's Degree Required
  • 3-5 years relevant regulatory experience
  • Experience compiling regulatory dossiers
  • Execution of FDA submissions

Work Rights

North America Applicants Only

Tailored Resume

Cover Letter