Regulatory Affairs Executive at Disphar International BV

• Oct 2017 - Present

1. Initial registration of Drug products in EU (Via DCP, MRP/RUP, NP procedure) & ROWmarket: Compilation and preparation of registration dossiers in CTD format as per theregistration guidelines of the health authority. 2. Handling of deficiencies received from Regulatory authorities and customers: Furnishingthe scientific responses to deficiencies received from various regulatory authorities andcustomers. 3. Post-registration activities: Preparation and Submission of post-registration variations(Administrative, Quality, Safety (Type IA/IAIN, IB & II, Article 5-Single or grouping) andArticle 61(3) notifications) to the multiple clients and ensure its approval, MA transfer, MA withdrawal, RMS transfer, Sunset clause exemption and renewals of marketingauthorizations. 4. Archival & Maintenance: Responsible for archiving and maintaining the files in theappropriate Document Management Systems (DMS), publish & maintain life cycle of eCTDsubmissions, Ready! update and Article 57 database update. 5. Submission Portals: Acquaintance with CESP, Portugal (SMUH-AIM) portal. 6. Dossier Compliance Checks: Performed dossier compliance check activity for 53 products. Co-ordination: Co-ordinate with various departments for collection of various technical documents asrequired for registration. 7. Co-ordinate with stakeholders and various customers for new registration, maintenanceof registration status for registered products and fees related activities. 8. Check BMR and BPR as per regulatory requirements. 8. Review change control and perform impact assessment on regulatory submissions Show less

Regulatory Affairs Executive

• Oct 2017 - Present

Executive-Regulatory Affairs

• Feb 2016 - Oct 2017

eCTD Dossier Preparation for EU Market: Compilation and preparation of registration dossiers in eCTD format as per the registration guidelines of the health authority. Handling of deficiencies received from Regulatory authorities and customers: Furnishing the scientific responses to deficiencies received from various regulatory authorities and customers. Post-registration of Dossier: Preparation and Submission of post-registration variations and renewals. Submission Portals: Acquaintance with CESP and Portugal portal. Co-ordination : Provide regulatory support and product information for all internal and external customers, stakeholders and project teams. Maintain registration documentation and associated electronic databases, in line with in-house procedures. Co-ordinate with various departments for collection of various technical documents as required for registration. Check technical documents as per regulatory requirements. Review change control and perform impact assessment on regulatory submissions Show less

Research Associate - Regulatory Affairs [Formulation]

• Aug 2014 - Feb 2016

 Registration and Post‐registration of products: Dossier preparation for EU Market in eCTD format. Compilation and preparation of dossiers (CTD & ACTD Format) for ROW market (South East Asia and SouthAsia) and ensure timely submission. Handling of Regulatory queries and variation filing. Review technical documents related to dossiers compilation and query response. Receipt & maintenance of Approved Normative Documents (AND) and packaging artworks. Ensuring timely management of license variations and renewals (COPP, FSC, Manufacturing License and GMP). Show less

Research Associate - Regulatory Affairs [API]

• Jun 2012 - Aug 2014

• Compilation, Preparation and Maintenance of post approval lifecycle of DMF:o Responsible for compilation and submission of Registration dossiers [CEP/ ASMF / DMF (USDMF / JDMF / CnDMF / KDMF/ Tanzanian DMF) / ACTD / TDP /TD (Brazil)] to the international health authorities and customers. o Co-ordinate with regulatory counterparts for regulatory, quality & compliance during and after approvals such as Amendment (USDMF/CEP), Annual Update (USDMF), Revision and Renewal (ASMF/CEP).o Co-ordination with various departments [R&D, QA, QC, Production and Packaging] for timely receipt and timely review of data to facilitate submission.o Review of various technical documents incorporated in various sections of registration dossiers regarding pre-registration and post-registration activities. o Support implementation of Quality by Design concept in various stages of product lifecycle.• Handling of deficiencies received from Regulatory authorities and customers:o Furnishing the scientific responses to deficiencies received from various regulatory authorities [CEP/ASMF (MRP/DCP/National/Centralised) /USDMF/KDMF].• Submission Tools :o Acquaintance with eCTD, SPL and Drug Listing tool.o Submission of CEP, USDMF and ASMF in eCTD format. KEY ATTAINMENT o Presentation: Quality by design & Design of Experiments (Advanced tool for Quality By Design).o SOP Preparation: Prepared SOP for Initiation, Compilation & Submission of Registration Dossiers for active pharmaceutical ingredients (API) & Drug intermediates and training conducted for the same.o To maintain 1 lifecycle for eCTD Submissions: Resubmission of Active Substance Master File in eCTD format to facilitate future eCTD lifecycle management for various API. Show less

Senior Officer [Quality Assurance] - API

• Mar 2011 - Jun 2012

• Documentation : o Handling of change control, deviation, CAPA, OOS/OOT, Reprocessing/ Reworking, Return goods. o Preparation and review of validation protocols and reports. o Preparation, review and upkeep of Master BPR, Master SOP’s. o Responsible for BPR Issuance, receipt, controlled copies issuance/withdrawal. o Review of Analytical dockets and Batch Production Records for Batch Release and giving usage decision through SAP for batch dispatch, MSC2N transactions. o Review, Repacking - Relabeling Record. o Initiation and review of stability study. o Forwarding details required for filing DMF and their annual updates to Regulatory Affairs department. • Line clearance, GMP compliance and other activities: o Line clearance during production activities (e.g. new equipment installation and cleaning, cleaning after product change over, etc). o QA co-ordinator i.e. taking plant rounds, maintaining cGMP compliance, tracking of product quality, and maintenance of product file, monitoring dispatches and other plant related documents. o Conducting cGMP training and evaluation for the same. • Audit: Contributed in preparation of USFDA and various customer audits. Show less

Assistant Pharmacist [Quality Assurance] - Formulation

• Feb 2010 - Mar 2011

• IPQA & Documentation: Monitoring the routine production in process checks and review of BMR, BPR & Daily Logs. • Validation: Participated in Process Validation, Cleaning Validation, HVAC Validation, Tunnel Validation and Media Fill (Aseptic process validation). • Instruments Handled: UV Visible Spectrophotometer, pH Meter, Lux Meter, Air Borne Particle Counter. • Audit: Contributed in preparation of WHO audit and various customer audits. • IPQA & Documentation: Monitoring the routine production in process checks and review of BMR, BPR & Daily Logs. • Validation: Participated in Process Validation, Cleaning Validation, HVAC Validation, Tunnel Validation and Media Fill (Aseptic process validation). • Instruments Handled: UV Visible Spectrophotometer, pH Meter, Lux Meter, Air Borne Particle Counter. • Audit: Contributed in preparation of WHO audit and various customer audits.