Regulatory Affair Associate at Stresert Services Limited

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

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