Volunteer PositionPerforming below mentioned activities alongside the professional chemists;• Carried out all activities in a safe manner according to Workplace Health and Safety regulations, GMP and ISO guidelines as specified by FMC quality system• Performed sampling and testing of packaging materials, raw materials, intermediate products and finished products according to standard operating procedures to verify they meet specifications • Prepared required solutions and… Show more Volunteer PositionPerforming below mentioned activities alongside the professional chemists;• Carried out all activities in a safe manner according to Workplace Health and Safety regulations, GMP and ISO guidelines as specified by FMC quality system• Performed sampling and testing of packaging materials, raw materials, intermediate products and finished products according to standard operating procedures to verify they meet specifications • Prepared required solutions and reference standardsChecked the calibration status of all laboratory equipment before use and ensured they are calibrated as per the calibration schedule• Maintained orderly storage of retention samples • Notified the Lab. Supervisor immediately of any discrepancies, out of specification results, low stock materials used in the laboratory including chemicals and glassware • Ensured all data is recorded on the correct forms in real time and on the appropriate registers• Assured changes to any recorded data are only made in the correct manner, signed and dated Show less

Established and lead Saliks Consultancy, specializing in regulatory affairs for health and agriculture authorities. Successfully managed the preparation, submission, and compliance of registration dossiers with Turkish Ministry of Health, Ministry of Agriculture, and related authorities. Provided medical translation support and handled post-approval activities, including variations, renewals, and license applications.

Prepared and managed registration dossiers, ensuring compliance with Turkish and international regulatory requirements. Played a key role in post-approval activities, label changes, renewals, and GMP inspection submissions. Led regulatory teams, collaborating with various departments to fulfill regulatory requirements.

For animal medicinal products; Prepared and managed registration dossiers, ensuring compliance with Turkish Ministry of Food, Agriculture and Livestock and related authorities in other countries for all approved veterinary pharmaceutical products in line with local and / or regional regulatory requirements. Played a key role in post-approval activities, label changes, renewals, and GMP inspection submissions. Led regulatory teams, collaborating with various departments to fulfill regulatory… Show more For animal medicinal products; Prepared and managed registration dossiers, ensuring compliance with Turkish Ministry of Food, Agriculture and Livestock and related authorities in other countries for all approved veterinary pharmaceutical products in line with local and / or regional regulatory requirements. Played a key role in post-approval activities, label changes, renewals, and GMP inspection submissions. Led regulatory teams, collaborating with various departments to fulfill regulatory requirements. Show less

For human medicinal products;Prepared registration dossiers for CIS countries, MEA countries adhering to the deadlines. Dealt with post-approval activities. Kept up with the current regulations and ensured all submission dossiers and documentations are in compliance with regulations. Gathered, collected, recorded, tracked and verified data and information from multiple sources. Assisted the team leader. Worked closely with related departments to fulfill the regulatory requirements and… Show more For human medicinal products;Prepared registration dossiers for CIS countries, MEA countries adhering to the deadlines. Dealt with post-approval activities. Kept up with the current regulations and ensured all submission dossiers and documentations are in compliance with regulations. Gathered, collected, recorded, tracked and verified data and information from multiple sources. Assisted the team leader. Worked closely with related departments to fulfill the regulatory requirements and restrictions. Show less

For active ingredient and human medicinal products;Tracked up-to-date information regarding products, performed testing of the bulk-intermediate-final-stability products, reported analysis results, assigned daily duties of the staff, performed instrument calibrations , provided consumable supplies, sustained proficiency in HPLC, GC and MS techniques, prepared test solutions and reagents as required, used wet and instrumental techniques for testing, kept the procedures and instructions up… Show more For active ingredient and human medicinal products;Tracked up-to-date information regarding products, performed testing of the bulk-intermediate-final-stability products, reported analysis results, assigned daily duties of the staff, performed instrument calibrations , provided consumable supplies, sustained proficiency in HPLC, GC and MS techniques, prepared test solutions and reagents as required, used wet and instrumental techniques for testing, kept the procedures and instructions up to date within the scope of ISO 9001. Show less