Regulatory affairs associate

01/06/2023 Bayt.com
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Job Purpose :The registration of new drug products and the maintenance of registration of approved drug products in order to ensure viability of these products in the marketplace.Major Activities :* Ensure compliance to current country regulations: Awareness of current and new local regulations. Communication of any changes that may impact Novartis in a timely manner to the manager* New Product Registrations – With supervision, evaluate, and prepare drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favourable outcome* Maintenance of registered products – With supervision, maintain registration of currently approved products (initiation and preparation of variation/ labelling variations, Safety label changes updates and renewal applications as per the plan communicated from the manager).* Ensure With supervision submission of safety related documents (eg PSUR, RMP, PSMF/PSSF, safety signals) to HAs along with local cover letter/annex as required in a timely manner as required by the regulation* Share any communication, query received from HAs with relevant stakeholders and partner with relevant stakeholders to ensure timely feedback to HAs as required* Ensure – With supervision timely completion/response to HA requests, commitments.... * Maintain the internal RA-GDD database and RIM system accurate and updated* Ensure maintenance of a physical and electronic archive of all HAs communications.* Review– With supervision, approval of Promotional and Non Promotional Material for assigned products according to P3 directives and applicable local regulation, submission to HAs when applicable.* Develop and maintain– With supervision product information and NSS ensuring the correct distribution and use of the approved versions of these documents. * Ensure – With supervision Artworks creation and maintenance in line with required and approved information by HAs.* Ensure adherence to Global and local processes: Align – With supervision local working procedures with Global processes. Identify gaps in terms of implementation of global procedures and flag gaps and issues of non-compliance with urgency to the Manager. Provide input to global SOPs under review, if requested.* With Supervision, Ensure full support to Global and local regulatory compliance initiatives, and projects to enhance operational excellence.* Comply with all the mandatory RA-GDD training and Maintain updated records of RA-GDD training/compliance training* With Supervision, Update logistics with the RA-GDD related information for the completion of the projects (Site transfers, Mars codes changes, any potential variation that may bock the supply...)* Assist Medical Information and Quality Assurance with product detail requests wherever feasible. Assist Training Manager with Product Information training requirements wherever feasible.* Relationships within and outside the company - Develop and maintain good working relationships with other Novartis departments both locally and with Head Office and with health authority and industry bodies. Provide valuable regulatory advice as necessary.* Develop a good competitive intelligence and a clear view of the local market