Job Summary

• This Associate Principal Scientist in Pre-approval Pharmaceutical CMC will be responsible for developing and implementing CMC regulatory strategies for our Company's pharmaceutical pipeline products in accordance with global regulations and guidance’s, with a focus on small molecule respiratory/inhalation product development.
• Primary responsibilities include serving as a CMC Product Lead for assigned products, leading the development and execution of global product and project regulatory strategy(ices), and managing execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions.
• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable, and will receive 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: $142,400.00 - $224,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, 401(k), paid holidays, vacation, sick days

Skills & Requirements

Key Requirements

• 5+ years of relevant experience
• B.S. in biological science, engineering, or related field
• Regulatory CMC experience with complex drug-device combination products/inhalation products
• Proficient in English

Work Rights