Regulatory Affairs Associate at a Global Health Care Company - Alan & Grant

 Employment Nigeria 25-May-2023 ₦Not Available LAGOS , Administrative  

Alan & Grant - Our client is a global Health Care company that provides solutions to address the evolving needs of patients worldwide.

They recruiting to fill the position below:

Job Title: Regulatory Affairs Associate

Location: Lagos
Job type: Full time
Industry: Health Care

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 office
  • Detail-oriented and organized.

 

Method of Application
Interested and qualified candidates should:
Click here to apply online



Sorry the application deadline for this job has elapsed



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