12 Nov
|
Privi
|
Navi Mumbai
Role & responsibilities
- Prepare, draft, and submit regulatory dossiers and applications for product registration across international markets within defined timelines; ensure proper follow-up and coordination with concerned teams.
- Liaise with external consultants, government bodies, and regulatory agencies to expedite approvals and resolve queries efficiently.
- Collaborate with internal teams including R&D;, Quality, Manufacturing, and Supply Chain to gather necessary data for dossiers, technical documents, and compliance reports.
- Support the set-up of recent manufacturing and R&D; units abroad by preparing regulatory documentation, engaging with local authorities, and ensuring compliance with global standards.
- Manage state-wise and country-specific licensing requirements, including Provisional Registrations, Standardization of Specifications, Form G2/G3 filings, and permissions across multiple regions.
- Handle Show Cause Notices, regulatory inspections, and post-registration issues, preparing replies and attending hearings on behalf of the organization.
- Track changes in international regulations, ensuring updates are communicated and compliance strategies are adjusted accordingly.
- Maintain regulatory databases, submission trackers, and audit-ready documentation in line with industry best practices.
Provide guidance and training to internal teams on regulatory requirements and submission procedures.
Preferred candidate profile
- Interpretation and Analysis of the data.
- Product Development
- Validation of data
- Analytical Skills
- Presentation Skills.
Role: Legal & Regulatory - Other, Industry Type: Fertilizers / Pesticides / Agro chemicals, Department: Legal & Regulatory, Employment Type: Full Time, Permanent Role Category: Legal & Regulatory - Other Education PG: MS/M.Sc(Science) in Agriculture Key Skills Skills highlighted with ‘‘ are preferred keyskills Regulatory Affairs InterpretationAnalysis of dataProduct DevelopmentData ValidationAnalytical
📌 International Regulatory Affairs Manager (Navi Mumbai)
🏢 Privi
📍 Navi Mumbai