Job Description
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
Desirable Skills and Experience
- 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