Job Description

Requisition Number 375641BR

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

Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum requirements Education: Tertiary qualified - Pharmacy or Science (majoring in a life science or chemistry) with or without postgraduate qualifications.

Languages: Fluency in English and fluent in local language(s).

Experience/Attributes/ Professional requirements: - Good communication, organization and negotiation skills. - Dynamic, entrepreneurial and high self-motivated personality. - Excellent administrative management skills. - Cross functional team player - Very detail oriented and analytical skills. - Able to work with strict deadlines. - Result driven mindset (excellent problem solving & project management skills) with a high compliance mindset - Manage workload and unpredictable issues, requiring organizational skills. - Sense of effective organization and initiative (proactive & autonomous attitude). - Pragmatic and business sense. - IT skills, particularly in relation to using databases. - A minimum of 1 year of experience in regulatory affairs, dealing with regulatory authorities.

Division Global Drug Development

Business Unit REG AFFAIRS GDD

Company/Legal Entity NOV PHARMA MAR

Functional Area Research & Development

Job Type Full Time

Employment Type Regular

Shift Work No

Early Talent No