RA Manager GDD - Oman (Omani National)

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

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