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

leHACK

Base: $190,800.00 - $300,300.00; bonus/equity: eli...
Hybrid
Device regulatory affairs strategies
Autoinjector, inhalation, delivery system 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

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.
  • Support the drug-led CMC Product Team on assigned products and be accountable for the delivery of all assigned regulatory activities.
  • The salary range for this role is $190,800.00 - $300,300.00; The successful candidate will be eligible for annual bonus and long-term incentive, if applicable; We offer a comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits, retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

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.

Salary

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

Skills & Requirements

Must-have

  • Device Regulatory Affairs strategies
  • autoinjector, inhalation, delivery system products
  • technical content input and coordination
  • CMC submissions
  • global regulations and guidelines
  • drug-led CMC Product Team support

Nice-to-have

  • scientific curiosity and self-development
  • innovative and imaginative approaches
  • rapid, disciplined decision making
  • work well under pressure

Key Requirements

  • 10 years relevant experience (Bachelor's)
  • minimum 5 years experience (Ph.D.)
  • B.S. in biological science, engineering, or related field
  • Advanced degree preferred
  • Subject matter expertise in combination product regulatory development
  • Experience with IDE/IND/510(k) clearances/CE mark authorizations/NDA/BLA/post-approval experience

Work Rights

Not specified

Tailored Resume

Cover Letter