Director, Regulatory Affairs - Cmc

ICON Clinical Research, LP

US
Fully remote
Cmc regulatory strategy
Small and large molecule development
Biologics, peptides, radiopharmaceuticals
As a Director in CMC Regulatory Affairs, you will provide expert knowledge on exciting area of small and large molecules within the Global Regulatory Affairs, CMC team which forms part of our Regulatory Consulting Services Group

Job Summary

  • As a Director in CMC Regulatory Affairs, you will provide expert knowledge on exciting area of small and large molecules within the Global Regulatory Affairs, CMC team which forms part of our Regulatory Consulting Services Group.
  • Responsibilities include serving as a technical expert, managing the preparation of regulatory CMC submission documents, and facilitating submission approvals through leading communications and negotiations.
  • ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work life balance opportunities for you and your family.

Matching Summary

As a Director in CMC Regulatory Affairs, you will provide expert knowledge on exciting area of small and large molecules within the Global Regulatory Affairs, CMC team which forms part of our Regulatory Consulting Services Group.

Skills & Requirements

Must-have

  • CMC regulatory strategy
  • small and large molecule development
  • Biologics, Peptides, Radiopharmaceuticals
  • INDs/NDAs/BLAs/NDSs/ANDAs submissions
  • US FDA Drug listing
  • Drug establishment Registrations

Nice-to-have

  • foster an inclusive environment
  • professional development and enhancing skills
  • business development activities
  • people management an asset

Key Requirements

  • Bachelors degree in life sciences
  • Relevant pharmaceutical/biologics regulatory experience
  • Demonstrable experience in regulatory CMC role
  • Experience supporting business development
  • People management experience

Work Rights

Not specified

Tailored Resume

Cover Letter