| Job Summary The Document Control Specialist is responsible for managing, reviewing, and maintaining controlled documents related to pharmaceutical operations. The role requires a licensed pharmacist with hands-on experience in FDA applications, regulatory submissions, and document compliance to ensure all records meet regulatory and quality standards. |
| Key Responsibilities: • Manage and control all regulated documents in compliance with FDA and internal quality standards • Review, organize, and maintain regulatory documents related to FDA applications, licenses, and renewals • Ensure accuracy, completeness, and consistency of controlled documents prior to submission • Coordinate with regulatory, quality assurance, and operations teams for document updates and approvals • Track document versions, revisions, and archival in accordance with document control procedures • Support audits, inspections, and regulatory inquiries by providing required documentation • Monitor regulatory changes and ensure documentation aligns with updated FDA guidelines • Ensure timely submission and proper filing of regulatory and compliance-related documents |
| Qualifications / Requirements: • Bachelor’s Degree in Pharmacy • At least 1–3 years of experience in document control, regulatory affairs, or quality compliance • Hands-on experience with FDA applications, submissions, or renewals • Strong knowledge of FDA regulations and pharmaceutical documentation standards • Detail-oriented with strong organizational and document review skills • Proficient in MS Office and document management systems |
Job Features
| Job Category | Gregan 101 Medical |
| Benefits: | - HMO with Dental Benefit - Free Parking - Paid Leave |