Fatima Yusra

Pharmaceutical Regulatory & Business Development Professional with forte of onhands knowledge of Drug Laws, ICH Guidelines, cGMP Compliance, International Regulatory Requirements, Strategic Collaboration and Key Account Management for OEM projects, effective liaising expert to successfully execute and complete the assignments and projects related to regulatory / legal affairs and business development

Preparation of Drug Registration /Technical Dossiers as per CTD format for registration of new products for local manufacturing and export with DRAP. Preparation and submission of Drug Registration /Technical Dossiers on prescribed formats with DRAP ( Drug Regulatory Authority of Pakistan) of imported products acquired through strategic collaboration from overseas principals and resolving queries raised thereon. Ensures Regulatory Compliance as per the directives issued by DRAP, ICH Guidelines & directives issued from FDA, EMA and other Stringent/ Reference Regulatory Authorities relevent to the pharmaceutical products and cGMP. Assist Director Regulatory Affairs & Business Development with technical advise, deliverables and regular follow-ups regarding the approval and timely renewals of GMP, DML, ICH guidelines for International inspections / stautary regulatory Site audits, International Certifications/ pre-requisite product Registrations for export, preparing procedures and protocols related to compliance, etc. Coordinate with all relevant departments including but not limited to Technical Operations, R&D , QC & QA, Legal Affairs, Finance, Materials Management, etc to resolve the issues / queries / submit information on prescribed format required by by DRAP for matters relating to product registrations, GMP, DML renewal, CRF calculations, product specification, Drug Pricing etc. Reviews product Artwork and Specifications to ensure conformance with regulatory requirements as set by the DRAP and other International Regulatory authorities of relevant export markets . Coordinate and followup with Legal Affaiirs Department as well as edxternal Corporate consulatnts & Attorneys regarding the documentation and approvals of Intellectual Property Rights ( Trademarks & Copyright) of the company's products, court Cases , PQCB Cases as well as timely management and submissions related to Samples/Queries received from Drug Inspector and Drug Testing Laboratories. Key Account Management for Toll Customers ( Local Pharmaceutical Companies) and ensuring timely response and deliveries of the products manufactured under contract manufacturing arrangement.

MBA (Health & Hospital Management) Business Administration (Business) Jan 2020 - Present Institute of Business Management (IoBM) Karachi Doctorate Pharmacy May 2019 University of Karachi Karachi Associate Fundamentals Pharmacology & Biochemistry Jan 2020 Harvard Medical School USA Boston HMS External Education Associate Business Management (Business) Oct 2021 - Jan 2022 Institute of Business Administration Karachi Certification on Entrepreneurship Associate Public Health Sep 2020 Imperial College London London Certificate course on Foundation of Public Health Practice Associate Regulatory Compliance & US Health Law Fundamentals Nov 2020 University of Pennsylvania, USA 2020 Pennsylvania Associate Healthcare consumerism and Implication for Care Delivery Dec 2020 Northeastern University, USA 2020 Illinoi