Regulatory affairs manager

Job Description : Regulatory affairs manager gcc Regulatory Affairs (Formulation Division) – Middle East Region Sr. Manager – Regulatory Affairs (Formulation Division) To manage and lead regulatory affairs activities for the Middle East region, ensuring timely product registrations, lifecycle management, regulatory compliance, and effective coordination with health authorities, distributors, and internal stakeholders for formulation products. Key Responsibilities Develop and execute regulatory strategies for product registrations and approvals across Middle East countries. Prepare, review, compile, and submit registration dossiers in CTD/eCTD and country-specific formats. Coordinate with regulatory authorities, agents, and distributors for approvals, queries, variations, renewals, and product maintenance activities. Ensure timely submission of new registrations, renewals, amendments, variations, and line extensions. Review technical documents including specifications, analytical methods, stability data, validation reports, and manufacturing information. Monitor changing regulatory requirements and assess their impact on existing and pipeline products. Support product launches by ensuring regulatory approvals are obtained within defined timelines. Manage responses to regulatory deficiencies, queries, and inspection observations. Collaborate with R&D, QA, QC, Manufacturing, Supply Chain, and Business Development teams for regulatory compliance. Maintain regulatory databases and product registration trackers. Provide regulatory guidance to internal stakeholders and support audits and inspections. Lead and mentor the regulatory affairs team to achieve departmental objectives. Qualification M.Pharm / B.Pharm / MSc or equivalent qualification. Regulatory Affairs certification will be an added advantage. Experience10–15 years of experience in Pharmaceutical Regulatory Affairs. Minimum 5 years of experience handling Middle East markets. Strong experience in formulation product registrations and lifecycle management. Exposure to GCC, Saudi Arabia, UAE, Iraq, Jordan, Kuwait, Oman, Qatar, Bahrain, and other Middle East regulatory requirements. Required Skills In-depth knowledge of Middle East regulatory guidelines. Expertise in CTD/eCTD dossier preparation and submissions. Strong understanding of pharmaceutical formulation development and manufacturing processes. Excellent communication and stakeholder management skills.Project management and team leadership capabilities. Proficiency in MS Office and regulatory document management systems.

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