Strong knowledge of us and international gmp regulations
The role is responsible for developing and implementing global regulatory CMC strategies to secure market access for assigned biologic products
Job Summary
The role is responsible for developing and implementing global regulatory CMC strategies to secure market access for assigned biologic products.
Candidates must have demonstrated success in filing marketing applications, supplements, and variations for biologic products within strict timelines.
The company offers a comprehensive benefits package including medical, dental, vision, 401(k), and discretionary equity awards.
Matching Summary
The role is responsible for 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
Expertise in biologics development lifecycle
Global submission experience for BLA and MAA
Strong knowledge of US and international GMP regulations
Experience managing FDA and Health Authority interactions
Ability to author Module 3 Quality sections
Nice-to-have
Collaborative spirit and team mentorship skills
Creative problem-solving for regulatory challenges
Experience with contract manufacturers and CROs
Strategic negotiation and cross-functional leadership
Key Requirements
Minimum 8+ years in global CMC regulatory affairs
BS/BA in Biochemistry, Biology, or Pharmaceutical Science
Advanced degree preferred
Deep experience in Phase 1-3 and marketed product lifecycle