Principal Scientist (director), Regulatory Affairs-cmc

539

Base: $190,800.00 - $300,300.00; bonus/equity: ann...
Hybrid
15 years pharmaceutical industry experience
5 years regulatory cmc experience
3 years people management experience
This role provides regulatory leadership and oversight for a team developing global CMC strategies for small molecule respiratory products

Job Summary

  • This role provides regulatory leadership and oversight for a team developing global CMC strategies for small molecule respiratory products.
  • The position requires extensive experience with complex inhalation products including dry powder inhalers, nebulizers, and metered dose inhalers.
  • Candidates will manage resources, develop talent, and ensure high-quality regulatory submissions for IND/CTA and worldwide marketing applications.

Matching Summary

This role provides regulatory leadership and oversight for a team developing global CMC strategies for small molecule respiratory products.

Salary

Base: $190,800.00 - $300,300.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • 15 years pharmaceutical industry experience
  • 5 years Regulatory CMC experience
  • 3 years people management experience
  • Inhalation product regulatory strategy
  • Dry powder inhaler and nebulizer expertise

Nice-to-have

  • Master's degree in chemistry or pharmacy
  • Post-graduate degree preferred
  • Experience with drug-device combinations
  • Global regulatory guidance knowledge
  • Cross-functional collaboration skills

Key Requirements

  • Minimum 15 years pharmaceutical industry experience
  • Minimum 5 years Regulatory CMC experience
  • Minimum 3 years managing people
  • Master's degree in chemistry, Pharmacy, or related discipline
  • Expertise in inhalation product characterization studies

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter