Senior Manager, CMC Regulatory
Core
Lead or co-lead CMC regulatory development and submission activities for assigned marketed or development products.
Role type
Senior Manager, CMC Regulatory Affairs
Builds
Regulatory submissions (INDs, CTAs, NDAs, MAA) and agency responses for gene therapy and small molecule programs
Domain
Biopharmaceuticals / Gene Therapy / Rare Diseases
Required skills
CMC regulatory strategy, IND/CTA/NDA/MAA submission, ICH guidelines, change control assessments, global regulatory team collaboration, project management, stakeholder communication, inspection readiness, regulatory tracker management
Preferred skills
RAC certification, process improvement, Microsoft Office proficiency
Technologies
Microsoft Office (Word, Excel, Outlook, Adobe), regulatory/quality systems
Responsibilities
Develop CMC regulatory strategies, coordinate document preparation and submission to health authorities, lead CMC submissions and agency responses, ensure documentation compliance, support inspection readiness, maintain regulatory trackers
Seniority
Senior, hands-on IC with team leadership