Regulatory Affairs Professional

Job Description

Process/Sub-Process Responsibilities/Activities: Must have experience in international regulatory affairs, pesticide regulatory activities in overseas countries. Registration Requirements: Study the registration requirements in each country from time to time Identify the data availability from database and prepare gap analysis Dossier Preparation: Prepare the dossiers in prescribed format Document Preparation: Understand Global Harmonization System and prepare MSDS of both Technical and Formulation products Prepare other dossier related documents like Composition, Authorization letters, Specifications, labels and leaflets etc., as per regulations of each country Data Scouting: Find authentic data on Chemistry, Toxicity, Eco toxicity, Efficacy, Residues, and MRLs or any other information from public domain on active ingredients, and formulations Discussions: Internal discussions within regulatory team to improve knowledge and implement suggested strategies. Collaboration: Interact with Marketing, Quality Control, Product Development, R&D, and Manufacturing units to collect necessary documentation like Analytical Methods, COAs, MSDS, Label, leaflet etc., and samples from time to time