04 Aug
|
Quality HR India
|
Mumbai
04 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 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
Salary :- Upto 15.00 LPA
If you are interested for this opening please send updated resume on same mail with following details.
Total No. of Years Experience :-
Current CTC :-
Expected CTC :-
Notice Period :-
📌 Regulatory Manager (Mumbai)
🏢 Quality HR India
📍 Mumbai