Regulatory Affairs Associate at Alan & Grant

JOB SUMMARY

• The Regulatory Affairs Associate will support the regulatory affairs department in managing submissions, compliance documentation, and communication with regulatory agencies.
• This role involves ensuring that products are developed, manufactured, and marketed in accordance with applicable regulations and guidelines.

Key Responsibilities

•  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.)
•  Prepare applications and ensure submissions for post-approval changes (variations) 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
• Appropriately share any identified issues related to compliance and regulatory intelligence affecting lifecycle management
• Maintain adherence to Global and local/regional processes with respect to life-cycle maintenance activities.
• Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged promptly where necessary.
• Ensure compliance to local and global KPls.

Requirements

•  Minimum of B. Pharm
•  1-2 years of experience in a similar role
• Good communication and negotiation skills.
• Strong Knowledge of CTD dossier format
• Detail-oriented, organized and inter-personal skills