AlHaya Medical Company Ltd.
Regulatory Affairs Supervisor Jobs in Saudi Arabia
Key Responsibilities:
– Acts as responsible Regulatory Team member for assigned regulatory projects
– Preparation and filing of submissions including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, obtaining CPPs, and publishing.
– Prepares and/or reviews regulatory documentation in line with assigned timelines.
– Support the strategic and operational planning.
– Understands the Scope of Work, timelines and deliverables for a given project
– Prepare status reports and metrics for assigned projects
– Ensuring compliance with regulations set by SFDA.
– Maintaining familiarity with company product ranges
– outlining requirements for labelling, storage and packaging
– Keeping up to date with changes in regulatory legislation and guidelines
– Analyzing complicated information
– liaising and negotiating with regulatory authorities
– Preparing documentation according to company SOP
– Learn, develop and train
Qualifications/Experience:
– BS / Pharmacy degree
– 3-5 years’ Experience in Similar RA position in Saudi Arabia, with high knowledge of SFDA & GCC regulations.
– Strong experience for dossier evaluation
– Understanding of Regulatory strategy and
determination of documentation requirements.
– Using a variety of specialized computer applications e.g. Microsoft Excel, PowerPoint, eCTD, QMS, …etc.
– Previous Experience in DMF reviewing & vendor
qualification is preferable.
– Solid problem solving skills
– Ability to work independently and under pressure
– Organizational, follow up and time management skills
Languages:
– Fluency in English and Arabic, both spoken & written.