Regulatory Affairs CMC Coordinator

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

US - Remote

Graduate/Post Graduate with a life sciences degree


Regulatory Affairs

Full Time