Regulatory Affairs Associate
Saudi Pharmaceuticals Industries
مجموع سنوات الخبرة :6 years, 3 أشهر
•Responsible in preparation, review and compilation of complete dossier (M1 to M5 & Part1 to Part 4)
as Vnees, CTD and eCTD for SFDA and GCC Submission.
• Scientific writing, review, and compilation of submission documents like Administrative documents(Module1), quality overall summary (module 2), CMC quality drug product, drug substance(Module3), Non Clinical (Module4) and Clinical (Module5) Information
• Independently author and/or coordinate CMC activities for new registrations and life cycle management including variations, renewals, annual reports and line extensions to meet filing requirements.
• Coordination with different internal and external stake holder for require documents for marketing authorization, information sufficiently ahead of time, proactively following up for timely delivery.
• Coordination with R&D, QA/QC, P&D departments and DMF Vendors for registration documents.
• Filing eSDR application for registration of product in SFDA
• Compilation, Validation and Publication of eCTD dossier through Pharma ready.
• Plan and prioritise variation submissions based on nature/ criticality of change using information available (for example supply impact, compliance risk etc).
• Actively drive simple to moderately complex regulatory projects (functional or cross functional).
8. Act as process owners for simple to moderately complex regulatory procedures, ensure lifecycle of the procedure taking ownership for engaging with team to train and improve upon as and when needed.
9. Support Line Managers for readiness and participation of any health authority inspection.
• Participate in meetings with Client on a regular basis to understand the clients requirement and proactively support the team in meeting or exceeding the targets in terms of quality and quantity within the agreed timelines
• Perform Document Finalization/publishing Services including review and format Word files to comply with requirements, prepare final eCTD-compliant PDFs of CMC regulatory documents using publishing software, review the PDFs and edit as needed to ensure regulatory requirements are met
• Working on Veterinary and Human pharmaceutical products.
• Responsible for Post approval Variation/Changes of CMC module for all markets.
• To complete assigned activities like variations, Renewals, Annual report and compilation regulatory data as per submission plan under supervision of molecule manager.
• Self development and continuous improvement.
• Achievied the targets as defined by the management
SOFTWARES HANDLING
1) SAP (Regulatory Data base & Variation Data bas
2) SPIRIT - Global Information System
3) SAGE, SAndoz Global Exchange (Global Regulatory Document Management System)
4) Sandoz Trackwise (Change control Process)
5) LORENZ DocuBridge Five
6) Fee calculation for variation
• Preparation & compilation of product registration & re-registration dossiers as per eCTD, CTD & ACTD (Ireland) guidelines for Regulated and semi regulated market.
• Coordination with manufacturing plant concerned departments to source documents.
• Reviewing of all the documents as a part of registration administrative section & Chemistry, Manufacturing & Quality Control documents (CMC) section like Drug Master File, Specifications, Method of Analysis, and Certificate of Analysis, Product Development Report, Process Validation, Analytical Method Validation, Batch Manufacturing Record and Stability Data etc. with respective of their approvability from the agency.
• Literature searching and reviewing of all the documents as a part of Clinical and Non Clinical section like Risk Management Plan (RMP), Periodic Safety Update Report (PSUR), Bioequivalence Study, Bioavailability study etc. and prepare report.
• Knowledge of ICH quality guidelines.
• Preparation of package inserts, summary of product characteristics and patient information leaflet.
• Prepare & compile responses for regulatory deficiencies and monitoring the technical queries received from external parties (e.g. Regulatory Authorities, Agents & Distributor etc.)
• Arrangement of product samples as per country guidelines/client requirements.
• Coordination with client regarding documents requirements and query responses.
• Management of Product Life Cycle from Regulatory perspectives.
• Checking the text matter on artworks.
• Maintain records sheets of dossier status and documents.
• Working on various formulations like Tablets, Capsules, Implant tablet, Injectable, Gel and Transdermal Patches.
• Preparation & compilation of product registration & re-registration dossiers as per ACTD, CTD & country specific guidelines for ROW market (Asian, CIS, Latin Amrica, African Countries).
• Coordination with manufacturing plant concerned departments to source documents.
• Reviewing of all the documents as a part of registration administrative section & Chemistry, Manufacturing & Quality Control documents (CMC) section like Drug Master File, Specifications, Method of Analysis, and Certificate of Analysis, Product Development Report, Process Validation, Analytical Method Validation, Batch Manufacturing Record and Stability Data etc. with respective of their approvability from the agency.
• Literature searching for Clinical and Non-Clinical data and prepare report.
• Preparation of package inserts, summary of product characteristics and patient information leaflet.
• Artworks preparation for export registration & commercial products as per country/client requirements.
• Maintain records of dossier status, documents and samples.
• Arrangement of product samples as per country guidelines/client requirements.
• Preparation of Monthly report related to department work status.
• Working on various formulations like Tablets, Capsules and Pellets.
Successfully completed M.Pharm Project: “Design and evaluation of bilayer floating tablet of diltiazem hydrochloride” Scope of Project • Process development of formulation. • Method development of tablet. • Optimization and Evaluation of dosage form.
• B. Pharm Project: “Survey of sickle cell anaemia in Nandurbar district” • Poster Presentation at Ali Allana College of Pharmacy On 7th January 2014 .On “Sikhkhimic Acid Pathway”.