Regulatory Manager

5 hours ago

Mumbai, Maharashtra, India Quality HR Services Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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

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