Alan and Grant Regulatory Affairs Associate Jobs in Nigeria

Alan and Grant Regulatory Affairs Associate Jobs in Nigeria

Job Description

The client is a global health care company that provides solutions to address the evolving needs of patients worldwide.

The ideal candidate will Support the Regulatory Affairs team by preparing submissions for Marketing Authorization transfers (MAT) in the designated Cluster.

Key Responsibilities

Prepare applications and ensure submissions for MATs are made and follow up with the Health Authority for timely approval.

Maintain prompt submission of post approval commitments for MAT applications and other changes and provide timely responses to Health Authorities (HA) as required.

Support with the transfer, inventory management and archiving of regulatory documents

Maintain adherence to Global and local/regional processes with respect to life- cycle maintenance activities.

Develop and maintain good working relationships with the Health Authorities, providing feedback from Health Authorities regarding submissions made or any relevant changes (processes, guidelines, etc.)

Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged on time where necessary

Ensure compliance to local and global KPIs

Develop and maintain good working relationships with other company's functions/departments both locally and globally as well as with Health Authorities as required

Support activities as assigned by RA Managers

Appropriately share any identified issues related to compliance and regulatory intelligence affecting lifecycle management.

Timely submission of MATs 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

Ensure archiving of documents are done in accordance with internal KPIs and SOPs/WPs

Requirements

B.Pharm.

1-2 years Regulatory Affairs experience

Good communication and negotiation skills.

Good understanding of Microsoft office

Detail-oriented and organized

How to Apply

For more information and job application details, see; Alan and Grant Regulatory Affairs Associate Jobs in Nigeria

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