Regulatory Affairs Associate at Alan & Grant

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