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

39med

Base: $190,800.00 - $300,300.00; bonus/equity: ann...
Hybrid
Device regulatory affairs strategies
Cmc submissions for delivery systems
Technical content writing and review
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, and compassionate and sick days

Skills & Requirements

Must-have

  • Device Regulatory Affairs strategies
  • CMC submissions for delivery systems
  • technical content writing and review
  • global regulations and guidelines
  • scientific content assessment

Nice-to-have

  • scientific curiosity and passion
  • innovative approaches to problem solving
  • rapid, disciplined decision making
  • collaboration skills
  • work well under pressure

Key Requirements

  • 10 years relevant experience (BS)
  • 5 years relevant experience (MS/PhD)
  • B.S. in biological science, engineering, or related field
  • Advanced degree preferred

Work Rights

Not specified

Tailored Resume

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