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: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, retirement, paid holidays, vacation, and sick days
Skills & Requirements
Must-have
Device Regulatory Affairs strategies
technical content writing and review
global regulations and guidelines
drug-led CMC Product Team support
autoinjector/inhalation delivery systems
Nice-to-have
scientific curiosity and self-development
innovative approaches to problem solving
rapid, disciplined decision making
work well under pressure
Key Requirements
10 years relevant experience (BS)
5 years relevant experience (MS)
B.S. in biological science, engineering, or related field