A Regulatory Affairs Documentation Specialist prepares, compiles, and manages technical files and legal submissions to ensure company products comply with government rules. They act as a bridge between the business and health groups, handling drug or device registration paperwork, label reviews, and audit logs.
- Document Compilation: Write and format registration dossiers, clinical reports, and market applications using standard regional frameworks.
- Compliance Tracking: Update internal files, tracking databases, and change orders to match shifting local or global laws.
- Cross-Functional Support: Work with Research & Development (R&D), Quality Assurance (QA), and legal teams to gather verified product data
- Agency Correspondence: Assist in answering questions or requests from regulatory bodies like the FDA, EMA, or CDSCO.
- Review Materials: Check product labels, packaging, and marketing texts for legal accuracy.
Required Skills and Qualifications
- Education: Bachelor’s degree in pharmacy, life sciences, chemistry, or a related technical field.
- Attention to Detail: High accuracy in proofreading technical data and managing document audit trails.
- Technical Software: Familiarity with electronic Common Technical Document (eCTD) systems, document management systems, and MS Office.
- Knowledge: Basic understanding of regional regulatory guidelines, Good Manufacturing Practices (GMP), and internal Standard Operating Procedures (SOPs)
Pay: ₹18,000.00 - ₹22,000.00 per month
Work Location: In person
