Purpose of the Position
– Support English West Africa (EWA) Regulatory Affairs (RA) Team with lifecycle maintenance activities in EWA Cluster as well as preparing submissions for post-approval changes in EWA Cluster. – Follow up with Health Authorities to achieve conclusion of submitted applications and escalate where necessary. – Maintain all necessary Novartis databases (e.g. DRAGON, NOVARIM) to ensure regulatory compliance at all times. – Support RA Specialist by maintaining open communication with internal stakeholders such as NTO, CMC and the EWA RA Team as required and regularly provide feedback.
Major Accountabilities of the position – Prepare applications and ensure submissions for post-approval changes (variations) are made, and follow up with the Health Authority for timely approval. – Maintain prompt submission of post approval commitments and other changes and timely responses to HA as required. – Follow up with CMC and NTO for responses to deficiency letters received for submitted variations. – Maintain adherence to Global and local/regional processes with respect to life-cycle maintenance activities. – 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. – Develop and maintain good working relationships with Health Authority, providing feedback from Health Authority regarding submissions made or any relevant changes (processes, guidelines, etc.) – 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 well with Health Authorities as required. – Support RA projects as assigned by RA Manager and RA Specialist. – Appropriately share any identified issues related to compliance and regulatory intelligence affecting lifecycle management.
Educational qualification University degree in Pharmacy or other Life Sciences
Experience/ Skills/Competence – 1-2 years RA experience – Good communication and negotiation skills – Knowledge of CTD dossier format – Detail-oriented and organized – Good team player Good inter-personal skills
Method of Application
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: 22 Feb. 2021
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