Regulatory Affairs Manager

About the role

EZMA Med, a newly established pharmaceutical venture backed by EZMA Holding, is looking for a Regulatory Affairs Manager in Erbil to lead its regulatory operations. The role covers pharmaceutical manufacturing site and product registrations with the Ministry of Health Baghdad and KRG authorities.

Key responsibilities

• Lead pharmaceutical manufacturing site and product registrations with MOH Baghdad and KRG authorities.
• Prepare, review and submit regulatory dossiers (CTD/eCTD), including variations and renewals.
• Coordinate with international manufacturers to obtain GMP certificates, CPPs and technical documentation.
• Manage import permits, regulatory approvals and compliance requirements.
• Support GDP compliance, pharmaceutical licensing and regulatory inspections.
• Monitor regulatory changes and coordinate with internal departments and authorities for timely approvals.

Required profile

• Bachelor's degree in Pharmacy (BPharm/PharmD); postgraduate qualifications are an advantage.
• Minimum 5 years in pharmaceutical regulatory affairs, with proven experience in MOH Baghdad and KRG registration procedures.
• Demonstrated experience in site registration, product registration, variations and renewals, and with international manufacturers.
• Fluent Kurdish and English; Arabic highly preferred.

Required skills

• Strong knowledge of CTD/eCTD, GMP, GDP and Iraqi pharmaceutical regulations.
• Proficiency in Microsoft Office and regulatory documentation management.