Major Accountabilities

• New Product Registrations: Support the RA Team by preparing local dossiers for submission of drug registration applications in a timely manner and follow up of the application during the evaluation phase to achieve a favorable outcome
• Maintenance of registered products: Support the RA Team in maintaining registration of currently approved products  and filing timing renewal applications
• Maintaining DRAGON and other relevant databases with up to date and accurate information of the products under the supervision of the RA Managers.
• Provide feedback from Health Authority to the RA Team while following up on submissions made to the Health Authority.
• Relationship with Distributors: With minimum supervision, ensures all registration documents required for importation of products are provided to our distributors to ensure compliance.
• Develop and maintain good working relationships with Health Authority. Review the HA website regularly and ensure current information and updated guidelines are shared with the RA team and relevant regulatory databases are up- to-date and accurate
• Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner where necessary
• Ensure compliance to local and global KPIs
• Develop and maintain good working relationships with other Novartis functions/departments both locally and globally as required.
• Support RA projects and activities as assigned by RA Managers & RA Specialist
• Appropriately share any identified issues related to compliance and regulatory intelligence affecting lifecycle management.
• Handle any additional tasks provided by the RA Managers
• Support the RA Compliance Associate in cluster self-assessment and audit readiness activities as required
• Support data consistency management and CCEx activities. Support the RA Compliance Associate in the QC process by reviewing related records against requirements of SOP and/or regulations to assess the process compliance status. Ensure compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system.
• Contribute to labelling management and continuous improvement initiatives, review and comment on emerging regulatory labelling guidelines
• Support the maintenance of Country specific presentations in AWA cluster
• Ensure compliance to local and global KPIs
• Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner where necessary
• Support RA projects and activities as assigned by RA Managers & RA Specialist
• Appropriately share any identified issues related to compliance and regulatory intelligence affecting lifecycle management.

Key Performance Indicators.

• Timely registration of new drug products and re-registration of approved products
• Timely submission of post-approval changes (variations) and follow up with the Health Authority for approval.
• Ensure compliance with relevant Health authority guidelines and regulations
•  Address issues related to compliance with urgency as appropriate
• Accurate monitoring and maintenance of relevant regulatory information management system(e.g. DRAGON, Production Transfer Tool)
• Achieve 95% Regulatory compliance deliverables (compliance with relevant databases, trainings and any such deliverable)

Ideal Background.

Education: B. Pharm

Languages: Fluent in English (mandatory)

Experiences

• Minimum 1 year RA experience
• Good communication and negotiation skills. Good inter-personal skills.
• Good understanding of the regulatory landscape in EWA
• Detail-oriented and organized
• Good understanding of CTD dossier format