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About the Role
Manage, supervise and coach DRA associates to achieve the business objectives in term of new Launches and life cycle maintenance activities. Provide adequate training and guid ance to all junior regulatory associates as relevant New Product Registratio ns – With no supervision, set up the strategy evaluate, prepare and submit drug registration applications in a timely manner and follow throug h the application during the evaluation ph ase to achieve a favorable outcome Maintenance of registered products – With no supervisi on, maintain registration of currently approved products Product Information and Consumer I nformation – With no sup erv ision, maintain product information and consumer in formation ensuring the correct u se of the approved versions of these doc uments Relationships within and outside the company - Develop and maintain go od working rela tionships with other Nov a rtis departments both l ocally and with Head Office and with health authorit y and indust ry bodies, su ch as the SFDA. Provide valuable regulatory advice as nece ssary. Assist M edica l Information and Quality Assuranc e with produ ct detail req uests wherever fea sible. Ensure the compliance of Regulatory database system’s content & data maintenance activities (Dragon, Regulatory Intelligence Database ...etc.). Create, maintain, Review & approve products artworks & leaflets & set-up the proper plan for implementation. Create, review & maintain BSS for all promoted products. Review and approve Printed Packaging Material Sheet (PPMS) received via AQWA. Monitor, Communicate & distribute All SFDA new regulations & guidelines among all the concerned departments in the CPO, Regional RA team and Global RA team. Review, Analyze and implement All SFDA new regulations & guidelines. Review & approve promotional materials & activities in compliance with applicable company & country regulations & policies.
Key Perf orm ance In d i cato rs
Th e t imel y registratio n of ne w dru g products. Accurat e & timely m a intena nc e of products life cycle management. Accurate & timely update for Novartis products labels, leaflets and safety information. Timely & accurate development & implementation of new artworks for leaflets & folding boxes. High regulatory compliance percentage for SALTO reports & DRAGON & all other relevant databases. Kee p t he re latio n w it h a ll relate d p a rtie s (insi de & outsi de NVS ) a t th e to p leve l of respect , confidenc e & re liability. Performance management and coaching of the relevant DRA team. High regulatory compliance percentage for SALTO reports & DRAGON. Compliance of the promotional materials with the registered/approved PI.
Ideal Background
Education :
Bachelor Degree in pharmacy or any equivalent degree. Master degree is preferred.
Experience:
5-7 Years in Regulatory Field. Deep understanding of SFDA and GCC regulatory system and rules. Strong Management skills. Excellent organization skills and ability to work on a number of projects with tight timelines is required. Strong Negotiation & Analytical skills Strong Interpersonal & Communication skills Excellent Computer skills (Word, Excel & PowerPoint). Fluent in Spoken & Written English.
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Saudi Arabia REQ-10036644
Regulatory Affairs Manager
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