Name: Employee id: Job Title: Sr.Executive - RA Job Grade: G11B Function: Plant Regulatory Affairs Sub-function: Plant Regulatory Affairs Manager’s Job Title: DGM Skip Level Manager’s Title: NA Function Head Title: Sr.Vice President Location: Dadra No. of Direct Reports (if any) None Date of Joining: Job Summary Manage work related to Regulatory Affairs functions at Site Areas Of Responsibility 1 Monitoring for Documents compilation activities for New product filing , Re-Registration/renewals from plant dossier filing , sample requirements etc. 2 Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data/documents from plant. 3 Coordination with CRA, ADD, FDD, MSTG ,PMO ,Plant team and with other CFT Members for regulatory requirements related to Registration, Re-Registration, queries, and variation filing. 4 Product Life Cycle Management: Active participation in Change control committee meeting. – Discussion with different Stakeholders and decision for final variation category (After taking concurrence from CRA, Country RA and Customers if require). 5 Activities related to Variation management - Tracking of Variation filing, approvals and intimation to plant for implementation of changes. 6 Support plant for business continuity of products by filing variations wherever applicable. 7 Monitoring for circulation of Regulatory Approvals and commitment details to Plant Team for US and OAM and Approval package for emerging market. 8 Participation in all launch discussions with plant CFT , business team , CRA to identify gap & mitigation plan. 9 Circulation of Regulatory strategies and Guidelines, wherever applicable 10 Support plant during Regulatory Inspections. Travel Estimate Up to % Job Scope Internal Interactions (within the organization) Production/ Quality/MSTG/NPQC/CRA/FDD/ADD/PDD External Interactions (outside the organization) Customers / Country RA Geographical Scope Dadra Financial Accountability (cost/revenue with exclusive authority) N/A Job Requirements Educational Qualification M.Sc. /B.Pharm/M.Pharm Specific Certification N/A Skills Believe in Team work, Leadership Skills , Communication Skills Experience 7-8 Years
Job Title
Senior Executive