Regulatory Affairs Manager

Location:

Company:

Job Summary:

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: Bachelor’s or Master's degree in Agricultural Science, Chemistry, Agrochemicals.
• 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.