Regulatory Operations Specialist

Job Summary

Supporting the Regulatory Operations team remotely on a contract basis, the Regulatory Operations Documentation Specialist will assist in the preparation, formatting, and quality control of submission-related documentation for health authorities.

Key responsibilities

• Support document formatting and quality control in alignment with submission standards
• Assist in the remediation of PDF documents, ensuring regulatory compliance through proper bookmarking and hyperlinking
• Archive communications with health authorities and manage document retrieval from offsite facilities

Required qualifications

• High school degree required; Associate's degree preferred
• Proficient in Microsoft Office and Adobe Acrobat
• Experience with database systems; familiarity with Veeva is a plus
• Pharmaceutical industry experience is a plus, but not required
• Strong attention to detail and effective time management skills