Saliks Regulatory Consultancy

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.

Regulatory Affairs Specialist

DELTAMED AJANS VE DİL HİZMETLERİ A.Ş.

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.

Medicavet

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.

Nobel İlaç

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.

FAKO İLAÇLARI 

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.

Quality Control Chemist

Professional Coach, ACC

Chemical Engineer and results-driven professional with extensive experience in regulatory affairs and quality control within the pharmaceutical industry. Proven track record of securing regulatory approvals, establishing strong relationships with authorities, and managing testing processes. After all, eager to leverage my expertise and passion for regulatory affairs and quality control to contribute to a dynamic team focused on innovation and growth in the healthcare sector.

Taplio

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Petek Dervent, ACC

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