Job Description

Job SummaryManage work related to Regulatory Affairs functions at Site.Areas Of Responsibility1Monitoring for Documents compilation activities for New product filing , Re-Registration/renewals from plant dossier filing , sample requirements etc.2Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data/documents from plant.3Coordination 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.4Product 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).5Activities related to Variation management - Tracking of Variation filing, approvals and intimation to plant for implementation of changes.6Support plant for business continuity of products by filing variations wherever applicable.7Monitoring for circulation of Regulatory Approvals and commitment details to Plant Team for US and OAM and Approval package for emerging market.8Participation in all launch discussions with plant CFT , business team , CRA to identify gap & mitigation plan.9Circulation of Regulatory strategies and Guidelines, wherever applicable10Support plant during Regulatory Inspections.11Monitoring for Product permissions, test licences and lay out archival activities for Local FDA.Job ScopeInternal Interactions (within the organization)Production/ Quality/MSTG/NPQC/CRA/FDD/ADD/PDDExternal Interactions (outside the organization)Customers / Country RAGeographical ScopeHalolFinancial Accountability (cost/revenue with exclusive authority)N/AJob RequirementsEducational QualificationM.Sc. /B.Pharm/M.PharmSpecific CertificationN/ASkillsBelieve in Team work,Leadership Skills, Communication SkillsExperience10-12 Years

Sun Pharmaceutical Industries