Job Description

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 local regulations: Awareness of current and new local regulations. Communication of any changes that may impact Novartis in a timely manner to all relevant Stakeholders. Partner with relevant stakeholders to ensure timely implementation of new regulations and updating of local working procedures incase needed. New Drug Applications: evaluate, prepare and submit drug registration applications pursuant to applicable regulations and according to timelines captured in the registration plan Follow up through the application during the evaluation phase to achieve a favorable outcome. Support and follow up with the Patient access team in case the MA obtaining is subject to price negotiation with HAs Ensure life cycle maintenance of approved drug products: renewals, CMC variations, labelling variations, Safety label changes updates... Ensure 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 timely completion/response to HA requests, commitments Ensure maintenance of RA Regulatory database: May act as RIM system and CCex Superuser and Single Point of Contact for all CPO RA compliance activities as assigned by RA Head. Ensure correct and timely RA Regulatory database entries e.g. DRAGON, CCex, local trackers, etc. Ensure maintenance of a physical and electronic archive of all HAs communications. Ensure timely feedback to compliance related queries/surveys from various stakeholders e.g. from Global PIE, Global labelling, TechOps etc, Review, 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 product information and NSS ensuring the correct distribution and use of the approved versions of these documents. Initiate Change Request in Agile to create Mars codes for early launches and late launches, in collaboration with supply chain team. Artworks creation and maintenance in line with required and approved information by HAs. Ensure adherence to Global and local processes: Align local working procedures with Global processes. Identify gaps in terms of implementation of global procedures and flag gaps to relevant stakeholders. Provide input to global SOPs under review, if requested. Maintain Regulatory local working procedures. Audit/inspections: Work closely with QA and Patient Safety departments to drive the management of RA related deliverables raised in preparation or during audits and inspections. Support the development of RA related CAPAs to address audit/inspection findings and follow-up on timely closure of the CAPAs. Manage deviations and related CAPAs: Oversight of out-of-compliance cases in CPO/cluster, tracking of cases, identification of root causes and solutions. Ensure implementation of corrective action and evaluate effectiveness from time to time. Collaborates with RA Head and CPO QA to improve efficiency and functionality and maintain CPO compliance. Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner when necessary. Provide adequate training and guidance to all junior regulatory associates. Assist Medical Information and Quality Assurance with product detail requests wherever feasible. Assist Training Manager with Product Information training requirements wherever feasible. Cross-functional collaboration with Medical, Brand Mangers, Patient access, supply chain to ensure launches success Provide necessary input to Brand managers for IPS, Business cases... 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

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 5 years experience in regulatory affairs, dealing with regulatory authorities. Company/Legal Entity NOV PHARMA MAR