Cmc Author

ICON Clinical Research, LP

Homebased, UK
Fully remote
Author module 3 ctd documents
Regulatory affairs expertise
Pharmaceutical/cro industry experience
ICON Clinical Research is seeking a Senior Manager in Regulatory Affairs CMC to join their home-based team across various European countries. The ideal candidate will possess extensive experience in regulatory affairs, particularly with CMC knowledge, while contributing to clinical trial design and regulatory strategy development

Job Summary

  • ICON plc is a world-leading healthcare intelligence and clinical research organization.
  • As a Senior Manager, you will play a pivotal role in designing and analyzing clinical trials.
  • ICON offers a range of benefits focused on well-being and work-life balance opportunities.

Matching Summary

Match Score: 85

ICON Clinical Research is seeking a Senior Manager in Regulatory Affairs CMC to join their home-based team across various European countries. The ideal candidate will possess extensive experience in regulatory affairs, particularly with CMC knowledge, while contributing to clinical trial design and regulatory strategy development.

Skills & Requirements

Must-have

  • Author Module 3 CTD documents
  • Regulatory affairs expertise
  • Pharmaceutical/CRO industry experience
  • Strong organizational skills

Nice-to-have

  • Experience with peptides and proteins
  • Excellent written and verbal skills
  • Ability to manage multiple tasks

Key Requirements

  • In-depth regulatory affairs expertise
  • Experience with regulatory strategies
  • Demonstrable experience in clinical trials

Work Rights

Not specified

Tailored Resume

Cover Letter