Regulatory Affairs Associate Jobs In Dubai UAE 2023 | Sanofi

4 weeks ago


dubai, United Arab Emirates 慓潮楦 Full time
Regulatory Affairs Associate Jobs In Dubai UAE 2023 | SanofiEnsures the maintenance of the A.M.M.: renewals, variations, answers to the authorities, the coordination of the preparation of reports profit / risk. Extension of the recordings: evaluation of files, coordination of the update of the documentation, the definition of the strategies of recording. Job Family Group: Regulatory Affairs – GeneralistResponsibilities:
Responsible for the overall registration strategiesEnsure timely submission and drive approval of all Regulatory Activities in the Gulf RegionEnsure compliance of the product portfolio to the legal requirements of the marketsMaintains knowledge of regulatory requirements and environment up to dateWork closely with Internal and external stakeholdersSupport the submission preparation and approval execution for all Regulatory activitiesSupport effective communication with distributors and Health Authorities in GulfReview and approves promotional material in accordance with Health Authority legalization
Requirements:
Responsible for the overall registration strategies, coordination, implementation, execution, control and completion of product registrations in Bahrain, Kuwait, Qatar, Oman and UAE which is achieved by ensuring timely submission and driving approval through compliance of all Regulatory Activities in the Guff Region.Maintains knowledge of regulatory requirements up to date and provides regulatory intelligence and guidance on the changes (on going and future) to local Regulatory on regulations and guidelines including assessment of their impact on Sanofi’s portfolio and business.Work closely with Internal stakeholders on planning of regulatory activities in the Gulf RegionSupport the submission preparation in providing updated requirements and reviewing local documents.Support communication with our local agents and distributors in Gulf to achieve successfully submission, follow-up and approval of all regulatory activities managed by the Health Authorities in Gulf Countries.Coordinate locally the submission of regulatory documents and follow up on their approval, in accordance with the regulatory plan
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