• Application Deadline:
• Position: Regulatory Affairs Associate


• Job Type Full Time


• Qualification BA/BSc/HND


• Experience 1 - 2 years


• Location Lagos


• Job Field Law / Legal 
  

Job Description

• 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 offic