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Regulatory Strategy Lead – FDA Submissions & Lifecycle

Job in Columbia, Lexington County, South Carolina, 29228, USA
Listing for: The Ritedose Corporation
Full Time position
Listed on 2026-08-30
Job specializations:
  • IT/Tech
Salary/Wage Range or Industry Benchmark: 96000 - 125000 USD Yearly USD 96000.00 125000.00 YEAR
Job Description & How to Apply Below
Location: Columbia

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

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