Job Description

Job Location: The Ritedose Corporation - Columbia, SC 29203
Salary Range: $66,607.00 - $76,596.00 Salary/yearThe Regulatory Affairs Specialist supports the Regulatory Affairs team in ensuring company products comply with applicable regulatory requirements. This entry-level role assists with regulatory documentation, tracking submissions, and maintaining compliance records while gaining hands-on experience with regulatory processes under supervision.
Responsibilities:
- Assist in the preparation and maintenance of regulatory submissions, registrations, and product documentation
- Support the tracking of regulatory approvals, renewals, and change notifications
- Maintain regulatory files, databases, and document control systems
- Assist with responding to regulatory agency requests and internal audits under supervision
- Monitor and summarize regulatory updates and guidance documents
- Provide administrative and technical support to Regulatory Affairs team members
- Collaborate with Quality, R&D, Manufacturing, and other teams to gather required documentation
- Support post-market activities such as product changes, renewals, and reporting
- Prepare, review, and issue documentation to support product development activities

Qualifications:
- Bachelor of Science Degree (degree in Regulatory Affairs preferred) with no professional experience or Associates Degree in a scientific discipline with at least two years of professional experience in pharmaceutical industry
- Understanding of cGMP documentation requirements
- General proficiency with MS Office including word processing and database software
- A high level of integrity and attention to detail
- Must work efficiently with moderate supervision
- Excellent written and verbal communication skills and strong interpersonal skills