Regulatory Affairs & QA Manager

About the role

We are seeking an experienced Regulatory Affairs & Quality Assurance Manager to lead our regulatory and quality initiatives across Jordan, GCC countries, Iraq, and Lebanon. The role involves managing drug registration, ensuring compliance with local and international guidelines, and supporting manufacturing site accreditation.

Key responsibilities

• Evaluate drug dossiers and regulatory documentation.
• Prepare and submit drug registration files in eCTD format.
• Manage regulatory submissions and follow‑up with health authorities.
• Coordinate manufacturing site accreditation and compliance activities.
• Handle post‑authorization variations, renewals, and SOP implementation.
• Ensure compliance with Good Distribution Practice (GDP) requirements.

Required profile

• Bachelor’s degree in Pharmacy.
• Minimum 10 years of experience in Regulatory Affairs and Quality Assurance within the pharmaceutical industry.
• Strong knowledge of regulatory requirements in Jordan, GCC, Iraq, and Lebanon.
• Proven experience with eCTD preparation and dossier submissions.
• Excellent communication, organizational, and leadership abilities.

Required skills

• eCTD preparation
• Regulatory dossier submission
• Good Distribution Practice (GDP) compliance
• SOP development and implementation
• Manufacturing site accreditation