Position: Regulatory Affairs Manager
Location: Erbil
Job Summary:
EZMA Med, a newly established pharmaceutical venture backed by EZMA Holding, is looking for a highly qualified and ambitious Regulatory Affairs Manager to take a leading role in developing our regulatory operations.
Job Description:
- 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 pharmaceutical import permits, regulatory approvals, and compliance requirements.
- Support GDP compliance, pharmaceutical licensing, and regulatory inspections.
- Monitor regulatory changes and maintain compliance.
- Coordinate with internal departments and regulatory authorities to ensure timely approvals.
Qualifications:
- Education: Bachelor's degree in Pharmacy (BPharm/PharmD) required; postgraduate qualifications are an advantage.
- Experience: Minimum 5 years in pharmaceutical Regulatory Affairs, with proven experience in MOH Baghdad and KRG registration procedures.
- Strong knowledge of CTD/eCTD dossiers, GMP, GDP, and Iraqi pharmaceutical regulations.
- Demonstrated experience in manufacturing site registration, product registration, variations, and renewals.
- Experience coordinating with international pharmaceutical manufacturers.
- Excellent communication, organizational, and problem-solving skills.
- Languages: Fluent Kurdish and English; Arabic proficiency is highly preferred.
- Proficiency in Microsoft Office and regulatory documentation management.
