Shyam Chemicals - Manager - Regulatory Affairs

Description:

- Location: Mumbai, Maharashtra (Travel Required to factory in Gujarat + international trade shows).

- Company: Shyam Chemicals is a leading manufacturer of high-quality agrochemicals and copper chemicals, serving diverse industries in India and globally.

Job Summary:

- The Regulatory Affairs Manager will be the companys key expert in all matters related to the global registration of our agrochemical products. This critical role involves preparing, submitting, and managing regulatory dossiers to obtain and maintain licenses required for the export and sale of products in target countries, ensuring continuous compliance with international standards.

Key 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.

Qualifications:

Education:

- Bachelors or Master's degree in a related field.

Experience:

- 5-8 years of direct experience in Regulatory Affairs, specifically managing global registration submissions for agrochemicals (Fungicides, pesticides, or insecticides).

Technical Knowledge:

- 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).

Skills:

- 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.

Show more Show less