Web Analytics
Novartis Pharmaceuticals Recruitment 2021 June 2021 - Jobvacan
Everything on JUMIA

Novartis Pharmaceuticals Recruitment 2021


 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 Description

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.

Advertisement

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.

Minimum requirements

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

Everything on JUMIA
>