Regulatory Affairs Operations Specialist

The 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