About this role
Role Overview
- Author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs
- Prepare and review CMC packages
- Support GMP submissions
- Manage change control assessments
- Ensure compliance with regulatory requirements across multiple regions
- Collaborate with project SMEs and client stakeholders to prepare submission packages
- Act as main GRA point of contact for LRAs and other stakeholders
Requirements
- A degree in biological or health sciences (Regulatory Affairs preferred)
- At least 5 years of experience in CMC regulatory affairs within the biotech or pharmaceutical industry
- Strong technical regulatory expertise
- Excellent writing skills
- Ability to evaluate scientific CMC information for accuracy
Benefits
- Competitive salary
- Flexible working hours
- Professional development opportunities
- Work from home options