RA Manager GDD - Oman (Omani National) job opportunity at Novartis.

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DatePosted 5 Days Ago bot
Novartis RA Manager GDD - Oman (Omani National)
Experience: General
Pattern: full-time
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degreeGeneral
loacation Oman, Oman
loacation Oman....Oman

Job Description Summary We are hiring for a RA Manager role in Oman. This role will provide effective regulatory support to Oman for new product registration, regulatory maintenance , and regulatory intelligence activities. This role is only for Omani Nationals who are based in Oman currently. #LI-Onsite   Job Description Ø NEW PRODUCT REGISTRATION ·        Implementing the registration of priority / new products in Oman as per the agreed yearly objectives. With minimum supervision, evaluate, prepare and submit drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favourable outcome for registration and pricing. ·        Coordinate with Regional Brand Regulatory Managers (RBRMs) in Basel and Hyderabad team to ensure having the registration requirements on time, hence fast submission / approval of new products. ·        Coordinate with 3rd party suppliers for reference / related substance requests from the MOH. Ø 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 assigned countries ·        Ensure speedy approvals from Health Authorities in assigned countries ·        Update local registration files with new ‘CMC, PT & Update’ approvals ·        Update the approval to Regulatory team in Hyderabad and logistics for assigned countries, by sending notification. ·        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 the assigned countries ·        Request all required documentation concerning manufacturing site registration from Basel and support team in India ·        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 ·        Coordinate with maintenance group Team Leader to ensure correct and speedy implementation / consignments ·        Develop and maintain good working relationship with DRA Team in Middle East Cluster and Indian DRA support team ·        Develop and maintain strong relationship with the Health Authorities and Agents in the assigned countries De-registration of pruned products - responsibilities: ·        Initiate de-registration of pruned products without affecting the existing stock, coordinating with the respective countries and keeping informed the country managers ·        Update local registration files with submission and/or confirmation from HA for the de-registration ·        Update the de-registration to Regulatory team in Hyderabad and logistics for assigned countries Divestment projects - responsibilities: ·        Provide necessary supports to the responsible parties of the acquired companies for the Novartis products divested to them. ·        Provide necessary maintenances (CMC/PT/Renewals) to the divested products until the divestment process is completed ·        Necessary follow-ups until the Marketing Authorization of the divested product is transferred to the new company Renewal: ·        Co-ordinate with Renewal coordinator ME in Regional office to ensure the registration renewal is submitted and approved in assigned countries as per the local regulations and the renewal plan. LABELING: ·        Coordinate with logistics to ensure availability of correct pack in assigned countries. ·        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. QUALITY ASSURANCE RESPONSIBILITIES: ·        Assist Quality Assurance  Manager for QA issues in assigned countries.  Regulatory intelligence Responsibilities: ·        Developing and maintaining Healthy professional relationships with MOHs in assigned countries. ·        Monitor competitor activities. ·        Establish and maintain the Health Authority stakeholder mapping. ·        Establish and maintain regulatory country fact book. ·        Design and implement Health Authority management plan. ·        Effective identification and communication of regulatory changes and emerging opportunities in assigned countries. ·        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 BOQ including: -        DRAGON updates and verification. -        Registration and implementation of labelling changes. -        Submission of Risk Management plans (RMP) and Periodic Safety Update Reports (PSURs). -        Ensue submission of new Safety updates received from DRA Regional office ·        Update logistics with the DRA 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. ·        Monthly update of the registration data sheet (RDS) for Oman based on “Global project list”, in order to have a plan for registration and/ or launch 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. ·        Monthly reporting regulatory activities to Head Regulatory affairs Department – ME cluster. ·        Provide regulatory advice to country managers in Oman. ·        Develop and maintain healthy working relationship with colleagues in DRA department and with other Novartis department both locally in the ME , Hyderabad DRA support team and with Head office. ·        Develop and maintain strong relationship with the Health Authorities and Agents in the assigned countries   Skills Desired Clinical Trials, Detail-Oriented, Drug Development, Life Science, Negotiation, Regulatory Compliance

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