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

Mayoly

$190,800.00 - $300,300.00; bonus/equity: annual bo...
Hybrid
Device regulatory affairs strategies
Device cmc regulatory activities
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

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 successful candidate will be eligible for annual bonus and long-term incentive, if applicable, and offered 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

$190,800.00 - $300,300.00; Bonus/Equity: Annual bonus and long-term incentive, if applicable; Benefits: Comprehensive package of benefits

Skills & Requirements

Must-have

  • Device Regulatory Affairs strategies
  • Device CMC regulatory activities
  • technical content writing and review
  • global regulations and guidelines
  • autoinjector and inhalation products

Nice-to-have

  • scientific curiosity and continuous learning
  • innovative approaches to problem solving
  • collaboration and rapid decision making
  • work well under pressure

Key Requirements

  • 10 years relevant experience (Bachelor's)
  • 5 years relevant experience (Master's)
  • B.S. in biological science, engineering, or related field
  • Advanced degree preferred
  • Subject matter expertise in combination product regulatory development

Work Rights

Not specified

Tailored Resume

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