RA Manager GDD - Oman; Omani National

*** 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.

• Implement 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 the 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.

• Receive and archive all ‘CMC, PT & Update’ that are dispatched by the 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 the Regulatory team in Hyderabad and logistics for assigned countries by sending notification.
• Coordinate with the maintenance group – Team Leader to ensure correct and speedy implementation / consignments.

• Ensure new/renewal of registration of manufacturing sites as per the new and mature products registration plan in the assigned countries.
• Request all required documentation concerning manufacturing site registration from Basel and the support team in India.
• Ensure speedy submissions and approvals of manufacturing site registration in the assigned countries in order to shorten the time of product registration.
• Update local archives for manufacturing site new/renewal of registrations.
• Coordinate with the maintenance group Team Leader to ensure correct and speedy implementation / consignments.
• Develop and maintain a good working relationship with the DRA Team in the Middle East Cluster and the Indian DRA support team.
• Develop and maintain a strong relationship with the Health Authorities and Agents in the assigned countries.

• 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 the Regulatory team in Hyderabad and logistics for assigned countries.

• Provide necessary support to the responsible parties of the acquired companies for the Novartis products divested to them.
• Provide necessary maintenance (CMC/PT/Renewals) to the divested products until the divestment process is completed.
• Follow up until the Marketing Authorization of the divested product is transferred to the new company.

• Co‑ordinate with the Renewal Coordinator ME in the Regional office to ensure the registration renewal is submitted and approved in assigned countries as per local regulations and the renewal plan.

• Coordinate with logistics to ensure availability of the 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.

• Assist the Quality Assurance Manager for QA issues in assigned countries.

• Develop and maintain healthy professional relationships with MOHs in assigned countries.
• Mo…