KMCA Representative – Regulatory Affairs

Awamedica is hiring!Job SummaryThe KMCA Representative – Regulatory Affairs will serve as the company’s primary liaison with the Kurdistan Medicines Control Agency (KMCA) and other relevant regulatory authorities. The role is responsible for coordinating product registration activities, monitoring regulatory submissions, ensuring compliance with regulatory requirements, and maintaining effective communication with regulatory bodies to support timely product approvals.Key Responsibilities:Act as the company’s official representative before KMCA and other relevant regulatory authorities.Follow up on product registration applications and monitor their progress through approval and inspection stages.Track registration timelines, pending requirements, and regulatory commitments to ensure timely completion.Obtain and communicate regulatory updates, procedural changes, and requirements to relevant internal stakeholders.Coordinate the collection and submission of registration documents from relevant departments.Liaise with KMCA officials regarding deficiencies, clarifications, inquiries, and regulatory correspondence.Attend meetings with KMCA and professionally represent the company’s interests.Ensure timely responses to KMCA requests, observations, and regulatory requirements.Coordinate activities related to the KMCA online system, including electronic submissions, system updates, troubleshooting technical issues, and registration-related matters.Prepare, coordinate, and follow up on registration fee payments and dossier-related financial requirements.Prepare and submit weekly and periodic regulatory status reports summarizing:Registration progressPending requirementsKMCA updatesDeficiencies and corrective actionsApprovals and certificates obtainedKey regulatory activitiesAdditional Duties:Support the Regulatory Affairs Department with online submissions, data uploads, dossier processing, and other registration-related activities following on-site KMCA visits.Maintain a high level of responsiveness to regulatory communications and inquiries.Manage multiple priorities effectively while meeting established deadlines.Ensure accuracy, completeness, and attention to detail in all documentation and submissions.Demonstrate strong follow-up, coordination, and organizational skills.Build and maintain professional working relationships with regulatory authorities and internal stakeholders.Qualifications:RequiredBachelor’s degree in Pharmacy.PreferredExperience with KMCA and Ministry of Health (MOH) registration procedures and regulatory submissions.Strong communication, coordination, and follow-up skills.Knowledge of pharmaceutical regulatory requirements and registration processes.Experience:3–5 years of experience in Pharmaceutical Regulatory Affairs.Proven experience in KMCA registration procedures, dossier preparation and follow-up, and coordination with KMCA departments.Experience dealing with regulatory authorities and managing product registration activiti