StreSERT Services Limited - We are recruiting on behalf of our client to fill the position below:

Job Title: Relationship Associate

Location: Lagos

Job Purpose
 Support EWA RA Team with life cycle maintenance activities in EWA Cluster
 Support EWA RA Team by preparing submissions for post-approval changes in EWA Cluster
 Follow up with the Health Authorities to achieve conclusion of submitted applications and escalate where necessary.
 Maintain all necessary company databases to ensure regulatory compliance at all times.
 Support RA managers by maintaining open communication with internal stakeholders such as NTO, CMC and the EWA RA Team as required and regularly provide feedback

Major Accountabilities
 Prepare applications and ensure submissions for post-approval changes (variations, renewals) are made, and follow up with the Health Authority for timely approval.
 Maintain prompt submission of post approval commitments and other changes and provide 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 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 in a timely manner where necessary
 Ensure compliance to local and global KPIs
 Develop and maintain good working relationships with other organization functions/departments both locally and globally as well as with Health Authorities as required
 Support RA projects and activities as assigned by RA Managers & RA Specialist
 Appropriately share any identified issues related to compliance and regulatory intelligence affecting lifecycle management.

Key Performance Indicators (KPIs)
 Timely submission of post-approval changes (variations) and follows 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
 Accurate monitoring and maintenance of relevant regulatory information management system(e.g. DRAGON, Production Transfer Tool)
 Achieve 95% Regulatory compliance deliverables (compliance with relevant databases, trainings and any such deliverable)

Ideal Background
Education (minimum/desirable): B. Pharm or BSc in life sciences
Languages: Fluent in English (mandatory)
Experience: 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.

Salary
 Very attractive

Method of Application
Applicants who meet the requirements listed above should forward their CVs to ‘outsourcing@stresert.com’ using position apply for as subject of the mail before 10th October, 2021