Regulatory Affairs
7 days ago
Key Responsibilities
- Prepare, compile, and submit Drug Master Files (DMFs), dossiers, and other regulatory filings for global and domestic markets, ensuring adherence to ICH, FDA, and local regulatory guidelines.
- Respond to queries from regulatory agencies and customers, ensuring accurate and timely communication, and preparing deficiency or clarification responses as required.
- Manage the entire product lifecycle, including regulatory submissions for renewals, updates, and variations, supporting product registrations and maintenance globally.
- Oversee the preparation, revision, version control, and archival of quality documents, ensuring compliance with GMP and regulatory standards.
- Support and coordinate with quality assurance for review and approval of documents related to manufacturing, testing, and quality processes.
- Act as a liaison between regulatory authorities and internal departments, integrating feedback and ensuring continuous compliance and improvement.
- Handle change control management, ensuring all regulatory updates, product/process changes, and risk assessments are accurately documented and submitted via RIMS (Regulatory Information Management System).
- Facilitate marketing and customer communications regarding regulatory status, product registrations, and required documentation in alignment with commercial and compliance priorities.
- Maintain up-to-date knowledge of global regulatory requirements, guidelines, and industry best practices, providing regulatory guidance to R&D, quality, and commercial teams.
- Support the technical committee by interpreting contemporary regulatory status, especially in relation to corrective and preventive actions related to compliance.
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