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.
Job Title: Regulatory Affairs Associate
– 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.
University degree in Pharmacy or other Life Sciences
– 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