Regulatory/Quality Assurance Expert

Regulatory/Quality Assurance Expert

Job Description

• Follow-ups with the Iranian Ministry of Health on files review and ensures timely submission of additional documentation requested • Supervision of quality processes • Familiar and provision of SOPs • Gathering Pharmacovigilance and ADR reports • Develop professional relationships with MOH staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations • Review documents as CTD, PMFs, to fulfill MOH requirement for registration • Familiar with TTAC portal of MOH and material registration. • Review product printing materials, labeling, specification sheets with applicable regulations and policies.

Requirements

• Education: Pharm. D. Pharmacist • Fluency in writing, reading and speaking of English language • Strong communication skills • Good command of computer knowledge (MS. Office) • High team work value • Interest and experienced in QA/Regulatory affairs

About Company

50-99 employees

Darou Darman Sepehr is the sole representative for Vitane Pharma which is a leading pharmaceutical company to supply high quality medicines and supplements in various lines including pediatrics, orthopedics, cardiology, gynecology and internal medicine.

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