Dania Alqhaiwi

•Pharmacovigilance Coordinator •Regulatory Affairs Coordinator •LSO deputy back-up

•Worked on electronic Patient Information Leaflets (ePIL) projects for different Pharmaceutical companies using XML-based workflows in alignment with Jordan Food and Drug Administration requirements. •Prepared, formatted, and validated electronic Patient Information Leaflets (ePIL) in XML format for regulatory submissions. •Ensured all XML content complied with JFDA guidelines and local regulatory requirements. •Collaborated with IT/digital teams for electronic deployment and archiving of XML leaflets.

DADvet •Led the implementation of CTD publishing and validation for the first time in the Company •Prepared regulatory dossiers and renewal submissions in compliance with deadlines •Plan the best pathway for product approval •Identify regulatory requirements in different markets (Jordan, GCC, MENA) •Advise internal teams on documentation and timelines •Review: • Technical data • Certificates (CoA, GMP, CPP) • Maintain accurate regulatory records •Act as the main contact with authorities (Veterinary Directorate – Ministry of Agriculture) •Respond to queries, deficiencies, and requests •Follow up on approvals and timelines •Work closely with: • Quality Assurance (QA) • Research & Development (R&D) •Review and approve:Labels,Package inserts (leaflets),Carton artwor& Ensure compliance with regulatory guidelines and language requirements •Support internal and external audits •Maintain internal regulatory databases

• Prepared registration files (TOC,CTD) ,Renewals and variations and ensured compliance with regulatory guidelines. • Followed up with regulatory authorities on product registration, variations, and renewals. • Handled Certificate of Pharmaceutical Product (CPP) and price certificate submissions to JFDA for export markets. • Prepared product renewal files and ensured submission to authorities. • Ensured company documents (COA, specifications, packaging designs) complied with regulatory requirements. • Updated and organized necessary documents in line with approved policies. • Reviewed drug master files (DMF) according to regulatory policies. • Coordinated with related departments (Quality Control, Planning, Quality Assurance) to fulfill registration requirements, including GMP and analytical certificates. •Filled EPI(Electronic Patient Information Leaflet).

•Conducted patient consultations to explain proper medication use and address health concerns. • Evaluated patient conditions to recommend appropriate medication therapy. • Collaborated with physicians and healthcare professionals to optimize patient care. • Dispensed medications and managed inventory, ensuring accurate stock levels. • Reviewed medication regimens for effectiveness and adherence. • Assisted in warehouse operations.