Director, Drug & Device Combo (autoinjector/inhalation) Reg.-cmc (remote)

29

Base: $190,800.00 - $300,300.00; bonus/equity: ann...
Hybrid
Device cmc regulatory activities
Autoinjector and inhalation products
Technical content input and coordination
Lead Device Regulatory Affairs strategies for autoinjector, inhalation, and other delivery system development programs by ensuring robust assessment of scientific content and critical evaluation of supporting regulatory documentation to confirm acceptability and identification of potential risks

Job Summary

  • Lead Device Regulatory Affairs strategies for autoinjector, inhalation, and other delivery system development programs by ensuring robust assessment of scientific content and critical evaluation of supporting regulatory documentation to confirm acceptability and identification of potential risks.
  • Support the drug-led CMC Product Team on assigned products and be accountable for the delivery of all assigned regulatory activities.
  • Apply an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval, product launch, and maintenance of market supply of our human medicinal products worldwide.

Matching Summary

Lead Device Regulatory Affairs strategies for autoinjector, inhalation, and other delivery system development programs by ensuring robust assessment of scientific content and critical evaluation of supporting regulatory documentation to confirm acceptability and identification of potential risks.

Salary

Base: $190,800.00 - $300,300.00; Bonus/Equity: annual bonus and long-term incentive, if applicable; Benefits: medical, dental, vision healthcare and other insurance benefits, retirement benefits, 401(k), paid holidays, vacation, compassionate and sick days

Skills & Requirements

Must-have

  • Device CMC regulatory activities
  • autoinjector and inhalation products
  • technical content input and coordination
  • global regulations and guidelines
  • drug-led CMC Product Team support

Nice-to-have

  • scientific curiosity and passion
  • innovative and imaginative approaches
  • superb collaboration skills
  • rapid, disciplined decision making

Key Requirements

  • B.S. in a biological science, engineering, or related field
  • 10 years relevant experience (BS) or 5 years (MS/PhD)
  • Subject matter expertise in combination product regulatory development
  • Experience with IDE/IND/510(k) clearances/CE mark authorizations/NDA/BLA/post-approval

Work Rights

Not specified

Tailored Resume

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