Cmc Author

ICON

Multiple Locations, , UK
Specialist ra cmc knowledge
Pharmaceutical/cro industry experience
Regulatory strategy development
At ICON, inclusion & belonging are fundamental to our culture and values

Job Summary

  • At ICON, inclusion & belonging are fundamental to our culture and values.
  • ICON offers a range of benefits focused on well-being and work-life balance opportunities for you and your family.
  • The role involves authoring Module 3 CTD documents, participating in strategic discussions, and acting as a regulatory affairs specialist.

Matching Summary

At ICON, inclusion & belonging are fundamental to our culture and values.

Skills & Requirements

Must-have

  • Specialist RA CMC knowledge
  • Pharmaceutical/CRO industry experience
  • Regulatory strategy development
  • Marketing authorization applications
  • Clinical trials regulatory expertise
  • Direct regulatory agency interaction

Nice-to-have

  • Experience with peptides and proteins
  • Familiarity with global regulatory requirements
  • Strong organizational and multitasking skills
  • Excellent written and verbal communication
  • Presentation and problem-solving skills
  • Interpersonal and management skills

Key Requirements

  • In-depth regulatory affairs expertise
  • Experience in pharmaceutical/CRO industry
  • Development of regulatory strategies
  • Document writing for regulatory submissions
  • Experience with marketing authorization applications
  • Experience with clinical trials and post-licensing activities

Work Rights

Must be based in UK, Spain, Germany or France

Tailored Resume

Cover Letter