Drug Master File (DMF) Management & Regulatory Compliance
1. Assist in the comprehensive review, preparation, and compilation of Drug Master Files (DMFs) in accordance with regulatory guidelines and internal standards.
2. Coordinate with Cross-Functional Teams (CFTs) to gather necessary data and documentation for DMF submissions, ensuring accuracy and completeness.
3. Maintain meticulous tracking of regulatory compliance activities, including changes related to product history and regulatory impact, and support timely filing of submissions.
4. Ensure all DMF sections and related documentation adhere to established regulatory requirements, ICH guidelines, and internal quality standards.
5. Review change controls and conduct product assessments to ensure alignment with fundamental regulatory requirements and internal specifications.
Query Handling & Cross-Functional Coordination
1. Efficiently handle regulatory and customer queries, providing timely and accurate responses.
2. Proactively follow up with Cross-Functional Teams (CFTs) to consolidate relevant data for drafting responses to queries.
3. Facilitate communication between regulatory bodies, customers, and internal teams to effectively resolve issues.
4.
Participate in cross-functional meetings to discuss regulatory strategies and ensure departmental alignment.
5. Act as a liaison between the Quality Assurance department and other operational units to ensure seamless information flow and provide guidance on regulatory matters.
Quality Assurance & Data Management
1. Contribute to maintaining high standards of quality assurance across all documentation and processes, identifying and proposing corrective actions for non-compliance.
2. Ensure all documentation is accurate, complete, and readily accessible for audits and inspections, collaborating with departments to keep quality-related documentation up-to-date.
3. Maintain accurate and up-to-date records of all regulatory documents and communications, utilizing data management tools for productive organization and retrieval.
4. Generate reports on regulatory compliance status, query resolution, and submission timelines, ensuring data integrity and confidentiality.
5. Stay updated with the latest regulatory changes and industry best practices to ensure ongoing compliance and contribute to continuous improvement initiatives within the QA department.