Regulatory Affairs Specialist

2 days ago

مصر, Egypt Target Recruitment & HR Solutions Full time

**Job Requirements**: - Pharmaceutical/Science Bachelor’s Degree or any related field. - 1-2 years experience in Regulatory Affairs, preferably with an FMCG/ pharmaceutical company - cosmetics an asset. - Local knowledge of some MENA regulations for cosmetics, medical devices, or pharmaceutical products. - Fluent in French. - Strong verbal and written communication skills in English. - Experience with MS Access or another database program is advantageous. - SAP Knowledge is an Asset. Product Registration and Regulatory Compliance - Handle new product registrations, product re-launch registrations, product renewals, site registrations, and marketing authorization holder registrations of cosmetics, medical devices, general sale list items, and health products. - Transpose registration data and dossiers in their required format and language to submit information to authorities. - Plan for the appropriate timelines of receiving, dispatching, and submitting all requested documents (legalized certificates, full dossiers &registration samples) to distributors, external labs, and concerned government authorities. - Coordinate orders for launch and re-launch samples. - Partner with relevant functional teams: distributors, production centers, health authorities, marketing affiliates, sales affiliates, and supply planners to ensure the successful continuity of business. - Write and update SOPs per country. - Establish contacts with local authorities. - Update and develop regulatory trackers with daily activities. - Review product regulatory compliance and correct/validate artworks for Cosmetics, Medical Devices, and Cosmeceuticals. - Manage artwork labeling elements and claims by communicating internally with Global Regulatory and R&D, collecting, and validating supporting documents and regulations to the government authorities. - Partner with the marketing team in assessing communication & testing protocols (TVC, advertisements, PIU). - Responsible for lab testing and required analyses. - Launch new brands in existing markets and introduce existing brands to new markets in the Region. **Regulatory Affairs Communication**: - Follow up on all regulatory affairs requests from HQ and production centers (PCs). - Monthly meetings with Marketing and Demand/Supply Planners (Triangle meeting). - Attend monthly meetings with distributors to ensure smooth operations. - Monitor regulatory developments and requirements/recommendations on the country level and communicate important issues to MENA Supply Chain Team and Marketing. - Lead negotiations with authorities on product classifications, new registration systems and documents required, and draft letters addressing any company concerns/ challenges to the authorities. - Study regulations and highlight the impact on Company products. Communicate with HQ and PCs for obtaining manufacturing site quality system certificates, certificates of free sale, and COA, GMP, and health certificates. - Support the Regulatory team on any administrative projects. - Provide information on local requirements upon request (e.g., product classification, regulatory clearance, specific packaging requirements). - Documentation and Reporting system - Maintain and update Regulatory Library with copies of all regulatory documents &country registration files (dossiers &registration certificates). - Build and update the product database. - Generate reports, summaries of regulatory data, and information for presentations or special regulatory affairs projects.

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