Regulatory Strategy Lead – FDA Submissions & Lifecycle

The Ritedose Corporation in Columbia, SC is seeking a Regulatory Affairs Manager to lead regulatory strategies for ANDA submissions and provide CDMO support for customer-led submissions (FDA and global). This role ensures compliance and lifecycle management in line with the Director of Regulatory Affairs.

Responsibilities include authoring and editing technical documents, serving as RA lead on teams, and publishing to FDA for lifecycle submissions while guiding junior staff and monitoring