We are currently seeking a Regulatory Affairs CMC Coordinator with 2 – 5 years of experience in a regulatory environment with a basic understanding of CMC activities to join our growing team.

Reporting to the Global Head of Regulatory and Safety, within the role, you will:

• Assist CMC experts in creating SharePoint templates for regulatory submissions
• Prepare submission-ready documents, bookmarking and reconciling
• Follow up with stakeholders on agreed timelines and escalate risks to respective stakeholders

• Basic understanding of CMC activities for regulatory submissions
• 2-5 years of experience
• Fluent in using SharePoint templates for creating regulatory submissions
• Competent in bookmarking and reconciling
• Very organized and skilled at preparing submission-ready documents
• Adept at interacting with multiple global stakeholders
• Able to follow strict timelines and provide immediate feedback when timeline risks are foreseen, or roadblocks occur
• Excellent oral and written communication skills
• Excellent interpersonal skills
• Excellent presentation and persuasive skills
• Self-driven with the ability to work with minimal supervision
• Ability to relate to technology in the Regulatory domain