Appointed Pharmacist / Regulatory Affairs Pharmacist

Company Description

A.L. Medi-Market is a licensed entity by the Israeli Ministry of Health, specializing in operating a Warehouse and Pharmacy for the distribution and preparation of medicinal drugs. The company offers an extensive range of medicines, pharmaceutical products, and medical devices to meet the ongoing needs of hospitals and medical clinics across Israel.

Appointed Pharmacist (IMOH)

• Act as the IMOH‑approved Appointed Pharmacist for pharmaceutical products
• Sign and take professional responsibility for MOH annexes, declarations, and registration dossiers
• Ensure accuracy, completeness, and regulatory compliance of all submitted data
• Serve as the official regulatory contact with the Israeli Ministry of Health

Regulatory Affairs

• Manage product registrations, renewals, and variations (Type IA/IB/II)
• Prepare and review regulatory submissions (CTD / national dossiers)
• Handle CEP / ASMF / API‑related changes, stability commitments, and shelf‑life justifications
• Coordinate regulatory responses to MOH deficiency letters and queries
• Liaise with manufacturers, MAHs, CROs, and international health authorities
• Support labeling activities (PIL, SPC, artwork) and lifecycle updates
• Work closely with QA, QP, PV, and supply chain teams to ensure ongoing compliance

• Licensed Pharmacist (recognized in Israel)
• Eligibility for appointment as Appointed Pharmacist by IMOH
• Academic degree in Pharmacy (B.Sc / M.Sc)
• Proven experience in Regulatory Affairs within pharmaceuticals
• Strong knowledge of Israeli MOH requirements, EU regulatory framework, and GMP/GDP
• Excellent written and verbal communication skills (English required; Hebrew advantage)

• Experience with imported medicinal products
• Hands‑on work with renewals, variations, and regulatory correspondence