01 Aug
|
Quality HR India
|
Mumbai
01 Aug
Quality HR India
Mumbai
Job Description:
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 current product development. Provide regulatory input for recent 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
Salary :- Upto 15.00 LPA
If you are interested for this opening please send updated resume on same mail with following d
📌 Regulatory Manager Mumbai
🏢 Quality HR India
📍 Mumbai