Lina Sayed Souleman Email & Phone Number

United Arab Emirates

• Managed supplier relationships, negotiated contracts (including Contract ManufacturingAgreements and Non-Disclosure Agreements), pricing, and payment terms for FDF (PrivateLabel), APIs, and Medical Devices.• Expertly managed product and supplier documentation for qualification ensuring they meetcompany standards. Acquired and reviewed key documents (CTD, DMF, COO, COA, CPP,..)and supplier credentials (GMP, ML, ISO, SMF,..), ensuring regulatory compliance.• Led supplier… Show more • Managed supplier relationships, negotiated contracts (including Contract ManufacturingAgreements and Non-Disclosure Agreements), pricing, and payment terms for FDF (PrivateLabel), APIs, and Medical Devices.• Expertly managed product and supplier documentation for qualification ensuring they meetcompany standards. Acquired and reviewed key documents (CTD, DMF, COO, COA, CPP,..)and supplier credentials (GMP, ML, ISO, SMF,..), ensuring regulatory compliance.• Led supplier performance evaluations to maintain high-quality partnerships.• Collaborated with logistics, finance, and QA teams for secure pharmaceutical product delivery,ensuring operational efficiency.• Led strategic projects like technology transfer for Biosimilar products.• Liaised with internal stakeholders to confirm delivery schedules, specifications, and quantities.• Conducted regular supplier follow-ups to ensure timely deliveries, escalating delays as needed.• Monitored the status of ongoing orders and shipments to ensure timely delivery and addressany issues that arise during transit.• Prepared and collected supply chain documentation for accurate order placement andconfirmation. Ensured shipping and delivery documentation such as PO, shipping instructions,PL, COO, BL, and PI.. were accurate and aligned with company requirements.• Supervised the development and implementation of procurement policies and procedures. Show less

North Macedonia

• Led product registration for diverse regions, including GCC, ensuring compliance andsuccessful registration of ~4 products annually.• Managed license and certification renewals, life cycle updates, and submission changes forseamless market access.• Directed acquisition of import licenses for raw materials and finished dosage forms (FDF).• Reviewed and approved product artwork, leaflets, and labels for regulatory compliance andaccuracy.• Oversaw organization and… Show more • Led product registration for diverse regions, including GCC, ensuring compliance andsuccessful registration of ~4 products annually.• Managed license and certification renewals, life cycle updates, and submission changes forseamless market access.• Directed acquisition of import licenses for raw materials and finished dosage forms (FDF).• Reviewed and approved product artwork, leaflets, and labels for regulatory compliance andaccuracy.• Oversaw organization and digital archiving of regulatory documents.• Presented regulatory updates and strategic recommendations to senior management; superviseda team of three.• Coordinated creation and maintenance of SOPs to meet regulatory requirements.• Handled communication with regulatory agencies and related contacts.• Addressed health authority inquiries and managed correspondence per regulatory guidelines.• Engaged with contract manufacturers and suppliers to obtain CTD, DMF, and technicaldocumentation; coordinated sample registration, as well as reviewing and approving artwork.• Provided regulatory guidance on projects impacting commercial operations and supply chain.• Monitored and managed application timelines, mitigating delays and aligning submissions withbusiness goals.• Identified and addressed non-compliance issues, supporting investigations and solutions. Show less

North Macedonia

• Assisted with product registration in various regions (GCC, Africa, Estonia, Malta, Turkey,Uzbekistan, Syria…), ensuring regional compliance.• Supported product registration renewals and maintained up-to-date licenses.• Managed import licenses for raw materials and finished dosage forms (FDF) in Syria, ensuringcompliance.• Compiled and submitted documents to regulatory agencies, meeting local and internationalstandards.• Researched regulations and industry… Show more • Assisted with product registration in various regions (GCC, Africa, Estonia, Malta, Turkey,Uzbekistan, Syria…), ensuring regional compliance.• Supported product registration renewals and maintained up-to-date licenses.• Managed import licenses for raw materials and finished dosage forms (FDF) in Syria, ensuringcompliance.• Compiled and submitted documents to regulatory agencies, meeting local and internationalstandards.• Researched regulations and industry standards for accurate product submissions.• Prepared and reviewed product artwork and labels for regulatory compliance.• Collaborated with departments to gather necessary documentation for registrations andcompliance.• Archived and digitized regulatory documents for organized record-keeping.• Monitored regulatory changes and updates, providing timely compliance information.• Created reports on regulatory submission status and renewals for internal team updates.• Resolved patient issues promptly to enhance clinic experience and satisfaction. Show less

Damascus, Syria

Syria

Damascus, Syria

• Coordinated patient appointments with scheduling software to optimize operations and minimizewait times, while providing exceptional customer service and addressing inquiries.• Warmly greeted visitors and managed incoming calls, emails, and correspondence, directing themto the appropriate team members.• Maintained an organized reception area and ensured confidentiality in all interactions.• Handled administrative tasks, including managing patient records, data entry… Show more • Coordinated patient appointments with scheduling software to optimize operations and minimizewait times, while providing exceptional customer service and addressing inquiries.• Warmly greeted visitors and managed incoming calls, emails, and correspondence, directing themto the appropriate team members.• Maintained an organized reception area and ensured confidentiality in all interactions.• Handled administrative tasks, including managing patient records, data entry, filing, and supportingvarious departments.• Assisted with office supplies and inventory management, scheduled meetings, and updated patientinformation in the clinic’s system.• Resolved patient issues promptly to enhance satisfaction. Show less

Bachelor'S Degree, Pharmacy

Bachelor'S Degree, Economics