The role involves developing and implementing global regulatory CMC strategies to secure market access for assigned biologic products
Job Summary
The role involves developing and implementing global regulatory CMC strategies to secure market access for assigned biologic products.
Candidates must have demonstrated success in filing marketing applications and managing interactions with the FDA and other global authorities.
The position offers a competitive salary range of $142,000 to $192,000 along with comprehensive benefits including equity awards.
Matching Summary
The role involves developing and implementing global regulatory CMC strategies to secure market access for assigned biologic products.
Salary
Base: $142,000.00 - $192,000.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off
Skills & Requirements
Must-have
8+ years global CMC regulatory experience
Expertise in biologics lifecycle management
Experience with FDA and global Health Authorities
Authorship of Module 3 Quality sections
Knowledge of IND, BLA, MAA processes
Nice-to-have
Strong negotiation and creative problem solving skills
Ability to mentor and train teams effectively
Experience with Veeva Data Management System
Willingness to travel 10-25% annually
Collaborative spirit and entrepreneurial mindset
Key Requirements
Minimum 8 years of global CMC regulatory affairs experience
BS/BA in Biochemistry, Biology, or Pharmaceutical Science
Advanced degree preferred
Deep expertise in biologics development and commercial lifecycle