Principal Scientist (director), Regulatory Affairs-cmc

29

Base: $190,800.00 - $300,300.00; bonus/equity: ann...
Hybrid
15 years pharmaceutical industry experience
Regulatory cmc experience with inhalation products
Dry powder inhalers (dpi) and metered dose inhalers
This role provides regulatory leadership and strategy for a team developing global CMC strategies for small molecule respiratory and inhalation products

Job Summary

  • This role provides regulatory leadership and strategy for a team developing global CMC strategies for small molecule respiratory and inhalation products.
  • The position requires managing complex submissions including IND/CTAs, Worldwide Marketing Applications, and transfer strategies to post-approval groups.
  • Candidates will benefit from a comprehensive benefits package including medical, dental, vision, 401(k), and an annual bonus eligibility.

Matching Summary

This role provides regulatory leadership and strategy for a team developing global CMC strategies for small molecule respiratory and inhalation 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

Skills & Requirements

Must-have

  • 15 years pharmaceutical industry experience
  • Regulatory CMC experience with inhalation products
  • Dry Powder Inhalers (DPI) and Metered Dose Inhalers
  • 5 years Regulatory CMC development stage experience
  • 3 years people management experience
  • Master's degree in chemistry or Pharmacy

Nice-to-have

  • Post-graduate degree preferred
  • Experience with drug-device combination products
  • Influence on Industry Association Whitepapers
  • Additional language skills beyond English
  • Participation in industry meetings

Key Requirements

  • Minimum 15 years pharmaceutical industry experience
  • Minimum 10 years with advanced degree
  • Minimum 5 years Regulatory CMC experience
  • Minimum 3 years managing people
  • Master's degree required; post-graduate preferred

Work Rights

Not specified

Tailored Resume

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