Fahime Sakhaie

Doctor of Pharmacy (PharmD) with 8+ years of experience across pharmaceutical regulatory affairs, product registration, technical documentation, GMP-related activities, community pharmacy and pharmaceutical research. Experienced in technical file and dossier preparation, regulatory submissions, regulatory correspondence, product specification review and pharmaceutical documentation. Strong understanding of GMP principles, quality documentation and pharmaceutical manufacturing requirements, with experience collaborating with QA, QC, Production and Regulatory Affairs teams.

Scientific background in pharmaceutical formulation, analytical testing, stability studies and in-vitro drug release. Published researcher with international peer-reviewed publications. Seeking opportunities within the UK pharmaceutical industry in Regulatory Affairs, Regulatory Operations, Product Registration, Quality & Compliance and Pharmaceutical Technical Operations.

Technical Responsible Pharmacist – Regulatory Affairs & Product Registration - Mehr Kian Pharmed Company - Tehran, Iran

(2021-12 - 2022-12)

Pharmaceutical Supplement Manufacturing

• Managed and reviewed technical and regulatory documentation for pharmaceutical supplement products.
• Supported product registration and regulatory submissions to the Iranian Food and Drug Administration (IFDA).
• Prepared, reviewed and maintained technical files, product dossiers and registration documentation.
• Conducted regulatory correspondence and follow-up with relevant regulatory authorities.
• Reviewed product specifications, manufacturing documentation, packaging materials and quality-related records.
• Supported compliance with GMP principles and pharmaceutical quality requirements.
• Collaborated with Production, QA, QC and Regulatory Affairs teams.
• Provided pharmaceutical expertise regarding formulation, product quality, technical documentation and regulatory compliance.
• Ensured completeness, accuracy and appropriate maintenance of regulatory and technical documentation.

Regulatory Affairs Specialist - Afa Chemi Pharmaceutical Company - Tehran, Iran

(2018-12 - 2021-12)

• Prepared and reviewed regulatory documentation for pharmaceutical products.
• Supported product registration and regulatory submission activities.
• Reviewed technical documentation, product specifications and regulatory files.
• Supported preparation and organisation of technical dossiers.
• Maintained accurate regulatory records in accordance with internal procedures and pharmaceutical requirements.
• Supported documentation processes aligned with GMP principles and pharmaceutical standards.
• Coordinated with relevant departments to support regulatory activities and product documentation.

Community Pharmacist - Community Pharmacy - Tehran, Iran

(2022-12 - 2026-09)

• Provided professional pharmaceutical services including prescription handling and medication counselling.
• Applied professional standards for safe and appropriate medication use.
• Managed pharmaceutical inventory, storage and product handling requirements.
• Maintained accurate pharmaceutical records and developed strong practical knowledge of medicines, dosage forms and pharmaceutical products.
• Communicated effectively with patients and healthcare professionals regarding medication use.

Doctor of Pharmacy - Pharmacy - Shahid Beheshti University of Medical Sciences (2010 - 2017)