Manager - Regulatory Affairs
Core
Lead regulatory activities for US, EU, and Canada markets for complex generic and drug-device combination products.
Role type
Manager, Regulatory Affairs
Builds
Regulatory strategies and eCTD submissions for complex generic products
Domain
Pharmaceuticals (Generic & Drug-Device Combination)
Required skills
Regulatory strategy development, New ANDA submission management, Agency query response handling, eCTD preparation and review, Controlled correspondence management, Pre-ANDA/Post-CR meeting coordination, Scientific advice interactions
Technologies
eCTD
Responsibilities
Lead regulatory activities for US, EU, and Canada markets; Handle Complex Generic Products and Drug-Device Combination Products; Manage New ANDA submissions and agency query responses; Develop regulatory strategies for complex generic product development; Prepare and manage Controlled Correspondence, Pre-ANDA Meetings, Post-CR Meetings, and Scientific Advice interactions; Support product development teams from a regulatory perspective; Prepare and review eCTD submissions
Seniority
Manager, 10-15 years experience