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Job Description
- Handle new product registrations, product re-launch registrations, product renewals, site registrations, 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 ®istration 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 successful continuity of business.
- Write and update SOPs per country.
- 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 country level and communicate important issues to MENA Supply Chain Team and Marketing.
- Maintain and update Regulatory Library with copies of all regulatory documents & country registration files (dossiers & registration certificates).
- Build and update product data base.
- Receive applications and set up the technical files.
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 French.
- Strong verbal and written communication skills in English.
- Proficiency in MS Office applications, mainly Excel and Word.
- Experience with MS Access or another database program is advantageous.
- SAP Knowledge is an Asset.
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