Job Summary

Position: Regulatory Manager

Location: Mumbai

Experience: 5 - 8 Years

Industries: Chemical

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 recent 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

📌 Regulatory Manager (Mumbai)
🏢 Quality HR Services
📍 Mumbai