Regulatory Affairs Manager
THE RITEDOSE CORPORATIONColumbia, South Carolina, United States
Posted April 3, 2026
96000 - 125000
Full Time
About the Company
The Ritedose Corporation specializes in contract pharmaceutical blow‑fill‑seal (BFS) manufacturing, producing small‑volume sterile and non‑sterile unit dose liquids. The company is a recognized leader in the BFS sector, with a portfolio that includes inhalation aerosols, eye drops, ear drops, and oral liquid formulations. Its expertise lies in delivering precise, scalable solutions for both sterile and non‑sterile products, ensuring compliance with rigorous quality standards. By combining advanced automation with a flexible manufacturing footprint, Ritedose offers clients rapid turnaround and cost‑effective production for a wide range of unit‑dose applications.
Job Description
The Regulatory Affairs Manager is responsible for supporting development and execution of regulatory strategies for ANDA submissions and CDMO support for customer-led submissions. Responsibilities include writing and editing technical documents, managing lifecycle activities, and ensuring compliance with regulatory requirements.
Requirements
- Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field
- 5+ years regulatory affairs experience with FDA submission experience required
- Experience with device and/or drug/device combination products preferred
- Ability to work on complex projects with minimal guidance
- Excellent written, verbal, and listening skills
- Experience using an electronic document control system and eCTD publishing software preferred
