Regulatory Manager

Job Summary Responsibilities

• Global Product Registration Dossier Management
• Lead the full registration lifecycle (pre-market research, submission, renewal) for all target export countries.
• Compile regulatory dossiers, including 5-batch analysis and efficacy data, ensuring strict adherence to national formats.
• Serve as the primary Point of Contact (POC) to coordinate data between R&D, factory, customers, and regulatory authorities for seamless submissions.
• Compliance and Policy Monitoring
• Monitor global regulations (e.g., MRLs, restrictions) and communicate changes to ensure continuous company compliance.
• Verify GLP/quality compliance of all required efficacy, toxicity, and environmental studies prior to submission. Ensure all outward documents (SDS, labeling, literature) conform to export market requirements.
• Strategic Administrative Support
• Develop strategies to accelerate product registration and market entry; provide regulatory input for new product development. Provide regulatory input for new product development projects to ensure technical feasibility and compliance.
• Maintain the master database of all submitted and approved product licenses and registration deadlines.

Required Skills

• Deep, current understanding of international regulatory frameworks, including the critical role of GLP-compliant data, 5-batch analysis requirements, and specific regional guidelines (e.g., BPR, US EPA, LATAM, SEA).
• Exceptional organizational skills, meticulous attention to detail, and proven ability to manage complex, multi-year projects. Excellent written communication skills for authoring regulatory documents and verbal skills for effective liaison with government agencies.

Required Qualification

• M.Sc/B.E/B.Tech - Chemical

Key Skills

• Regulatory Affair
• Regulatory