Global Regulatory Lead

Opella Inc.

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
The role supports the development and execution of regulatory strategies for drugs, medical devices, and combination products

Job Summary

  • The role supports the development and execution of regulatory strategies for drugs, medical devices, and combination products.
  • Candidates will prepare and manage key regulatory submissions such as INDs and NDAs while coordinating with publishing teams.
  • Opella is a globally certified B Corp company aiming to reinvent self-care for half a billion consumers worldwide.

Matching Summary

The role supports the development and execution of regulatory strategies for drugs, medical devices, and combination products.

Salary

Base: $111,000 - $160,333.33; Bonus/Equity: Not specified; Benefits: Eligible for 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 leadership
  • Competitor approval monitoring
  • Scientific input provision
  • Global regulatory initiatives support

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