Key Responsibilities :
• Develop and implement regulatory strategies for new product development, existing product maintenance, and market expansion.
• Prepare, compile, and submit regulatory dossiers and applications to regulatory agencies in a timely and compliant manner.
• Manage and maintain regulatory files, databases, and tracking systems for approvals, renewals, and variations.
• Ensure all products and processes meet applicable local, national, and international regulations.
• Monitor changes in regulatory requirements and standards globally and assess their impact on company products and
processes. Ensure ongoing compliance with all applicable regulations.
• Stay up to date with the latest developments in regulations, guidelines, and industry trends, assessing their impact on the company's products and operations.
• Provide expert regulatory advice to internal teams (R&D, manufacturing, marketing, legal, quality assurance) throughout the product lifecycle.
• Act as the primary point of contact and liaison between the company and regulatory bodies. Facilitate communication, address inquiries, and negotiate with regulatory agencies to obtain and maintain product approvals.
• Support regulatory inspections, audits, and external agency interactions. Prepare responses to regulatory agency questions, deficiencies, or findings.
• Review product labeling, packaging, promotional materials, and advertising for compliance with regulatory standards. Recommend courses of remediation to address areas of non-compliance.
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