ASLAM SOHAIL MOHAMMAD

Experience

• 

  Jamjoom Pharmaceuticals Company

  Mar 2015 - now

  Planning, preparation (including authoring) and delivery of CMC submissions.Interface with project team members to obtain documentation, establish timelines and ensure complete and accurate submissions are prepared according to plan.Ensuring the agreed submission strategy is executed and to provide complete CTD CMC module 2 and module 3 documentation per regulatory requirements.Accountable for delivering CMC modules to regulatory partners in compliance with relevant systems and procedures.Critically review technical information intended for submission to the Health Authorities for consistency to relevant International Conference of Harmonisation (ICH) CMC guidelines and to promote regulatory excellence.Maintain awareness and communicate CMC regulatory requirements to the project management team and cross functional team.Participate in product development process to provide the regulatory recommendations based on Health Authorities regulations, industry experience and the technical requirements to support the proposed product development.Review of the Drug Master File and communicating with API suppliers on additional requirements.Responding to the queries/deficiencies raised by regulatory/health authorities on the Drug Product Dossier.To collect the required Technical & other information from relevant department(s). عرض أقل Preparation and submission of Drug Product Registration & Renewal /Dossiers in CTD, NeeS and eCTD format as per regulatory requirement(MENA/Turkey/CIS/ & East Africa etc.). Preparation and submission of country specific Re-Registration/Renewal Dossiers Review of the Drug Master File and communicating with API suppliers on additional requirements.Responding to the queries/Deficiencies raised by Regulatory Agencies on the Drug product Dossier.Classifying and applying for variations where ever applicable.Coordination with Formulation Development to ensure the availability of product information, tentative pack samples, composition and manufacturing procedure.Coordination with Analytical method Development team to ensure the availability of raw material specification, finished product specification, raw material procedure, finished product test procedure, lab scale stability data of the product.Coordination with Export Department to obtain price certificate.Coordination with Artwork Designers for artwork design, Mock-ups and labels. Coordination with Warehouse Department to obtain samples, inserts, outer cartons and labels. Preparation of requests for Primary Reference Standards, Finished Product & packaging materials in SAPArranging GMP’s, COS & Declaration letters from different suppliers/vendors through supply chain.Updating the status of all dispatched Dossiers in Regulatory Information System RIS (ORACLE). To collect the required Technical & other information from relevant department(s). عرض أقل

  • Jr. Manager - CMC Regulatory Affairs

    Jan 2021 - now

  • Regulatory Affairs Sr. Executive

    Mar 2015 - now