Job Description

Job Purpose Provides effective regulatory support to the assigned country for the newly acquired products, marketing authorization transfer, regulatory maintenance activities, and regulatory intelligence activities. Major Accountabilities NEW PRODUCT REGISTRATION • 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 REGULATORY MAINTENANCE: CMC, PT and Update - responsibilities: • Receive and archive all ‘CMC, PT & Update’ that are dispatched by Regulatory team in Hyderabad • Prepare and submit the ‘CMC, PT & Update’ that are relevant to Iran • Ensure speedy approvals from Health Authorities in Iran • Ensure implementation of the CMC/PT and updates with no supply interruption in close collaboration with the supply chain manager for Iran. • Coordinate with maintenance group - Team Leader to ensure correct and speedy implementation / correct consignments New / Renewal of registration of Manufacturing site/s - responsibilities: • Ensure new/renewal of registration of manufacturing site as per new and mature products registration plan in Iran • Ensure speedy submissions and approvals of manufacturing site registration in the assigned countries in order to shorten time of product registration • Update local archives for manufacturing site new/renewal of registrations • Ensure implementation with no supply issues in close collaboration with the supply chain manager of Iran • Coordinate any pricing impact for the ST with finance/ and MA manager in Iran. MAH transfer - responsibilities: • Provide necessary supports to the responsible parties of the acquired products and establish proper strategy of submission/approval of the transfer • Provide necessary maintenances (CMC/PT/Renewals) to the transferred products products until the transfer process is completed in coordination with the internal and external stakeholders. • Coordinate properly with the supply chain, commercial team to ensure proper implementation of the transfer with no supply issues. LABELING: • Coordinate with logistics to ensure availability of correct pack in assigned countries. • Ensure labelling updates are submitted on time and in line with the local SOP. • Sign PPMS ( material and shipment approval ). • Answer manufacturing site queries concerning shipment approval/authorisations /pre license sale • Coordinate with Logistics/ chain supply/ Artwork teams and manufacturing site to obtain valid artworks and implementation dates. • Coordinate with Logistics/ chain supply/ Artwork teams and manufacturing site to ensure that the registered product specifications are compliant and being imported to each country. Regulatory intelligence Responsibilities: • Developing and maintaining healthy professional relationships with the health authority and local partners in Iran. • Monitor competitor activities. • Design and implement Health Authority management plan. • Effective identification and communication of regulatory changes and emerging opportunities in Iran. • Ensure transparency in Health Authority communication and interaction. • Ensure participation at relevant local trade association. OTHERS: • Ensure full support to Global regulatory compliance initiatives in assigned country including: - Database updates (where relevant) and verification. - Registration and implementation of labelling changes. - Submission of Risk Management plans (RMP) and Periodic Safety Update Reports (PSURs). - Ensure submission of new Safety updates received from RA Global. • Update logistics with the RA related information for the completion of Notification of Introduction (NOI). • Communicate pricing of new products / Re-pricing to local logistics department and global – operations department. • Regular update of the registration data sheet of the assigned country (based on Global plan, in order to have a registration and/ or launch plan for new products. The same being a very important tool which provides a registration update to various departments (Marketing, Medical, logistics etc.), at any time. • Bi-weekly reporting regulatory activities to RA Head, levant. • Provide regulatory advises to country head & logistics in the assigned countries. • Develop and maintain healthy working relationship with colleagues in RA department and with other Novartis department both locally in the ME , Hyderabad RA support team and with Head office. • Develop and maintain strong relationship with the Health Authorities and Agents in the assigned countries Key Performance Indicators • Timely transfer of newly acquired drug products • Effective regulatory intelligence activities and implementation of HA management plans • 100% regulatory compliance for DRAGON database. • Compliance KPIs ( training/ SLC/ audit outcome) • Renewal/ CMC/ST submission and implementation with no supply interruption Ideal Background