Global Labeling Lead - Homebased In The Uk

ICON Clinical Research, LP

United Kingdom
Competitive salary; benefits: various annual leave...
8 years regulatory affairs experience
Global labeling compliance expertise
Ccds and smpc generation skills
The role involves providing regulatory expertise to drug development teams on the submission of labeling components for agency approval

Job Summary

  • The role involves providing regulatory expertise to drug development teams on the submission of labeling components for agency approval.
  • Candidates will lead global labeling working groups to ensure consistency across core documents and regional product families.
  • ICON offers a competitive salary, diverse benefits including health insurance, retirement planning, and a global employee assistance program.

Matching Summary

The role involves providing regulatory expertise to drug development teams on the submission of labeling components for agency approval.

Salary

Competitive salary; Benefits: Various annual leave, health insurance, retirement planning, EAP; Not specified

Skills & Requirements

Must-have

  • 8 years regulatory affairs experience
  • Global labeling compliance expertise
  • CCDS and SmPC generation skills
  • European regulatory requirements knowledge
  • USPI development and revision

Nice-to-have

  • Strong communication and interpersonal skills
  • Ability to work independently in fast-paced environment
  • Experience leading global working groups
  • Collaborative team player mindset

Key Requirements

  • Bachelor's degree in scientific discipline
  • Minimum 8 years in regulatory affairs or labeling
  • Strong understanding of global regulatory guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter