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 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

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 (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days

Skills & Requirements

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
• Experience with IDE/IND/510(k) clearances/CE mark authorizations/NDA/BLA/post-approval experience

Work Rights