Senior Manager-Regulatory Affairs

Job Description

Business: Piramal Pharma Solutions Department: CRA Location: Kurla Travel: Moderate JOB OVERVIEW: Preparation of licenses application & filing them on governmental portals for approvals from Indian regulatory authorities required for manufacturing, marketing and export of products in domestic and overseas markets by PPL sites in India. KEY STAKEHOLDERS: INTERNAL: Manufacturing sites, R&D , Program management, Supply Chain, Marketing, site regulatory KEY STAKEHOLDERS: EXTERNAL: Govt. authorities like State FDA, CDSCO, FSSAI, CBN, NCB, custom officials, Customers etc REPORTING STRUCTURE: (Reports To/ Direct Reports Y/N): Direct report to General Manager-RA ESSENTIAL QUALIFICATION: Graduate RELEVANT EXPERIENCE: > 10 years KEY ROLES/RESPONSIBILITIES: KEY ROLES/RESPONSIBILITIES: Registration Application on various Government portals (CBN, Sugam, FSSAI & XLN India) for new user Id s creation. Follow up with State FDA Thane, CDSCO, FSSAI, NCB for grant of licenses Product Registration application in Form - 41 on DCGI Sugam Portal. Written confirmation (WC) application on DCGI Sugam Portal for API s. Preparation & Online Submission for Import License application in Form - 10 Preparation & Online Submission for CBN permissions (Import Certificates & Quarterly return filling) Preparation & Online Submission of API, RLD Test License Applications (Form-11 & Form CT - 17). Preparation & Online Submission of CDSCO permission in Form CT-11, CT-14 & CT-15, Dual Use NOC & Export NOC Preparation & Online Submission of application on state FDA portals like Test Licenses (Form- 29), wholesale license etc. , Preparation & Online Submission of various CBN application (Import/Export/Quota/Mfg. License). Quarterly return submission to CBN/NCB/State FDA Provide regulatory strategies and support all stakeholders w. r. t assessment of D&C Act Feedback on new guidance Review and assessment for selection of product for manufacturing at site as per the D&C act To create PR in SAP to process payment for various bills/Invoices received from consultants. KEY COMPETENCIES: written and spoken communications skills, cross functional collaboration, negotiation skills, meticulous planning and execution for timely receipt of approvals ESSENTIAL QUALIFICATION: Graduate