Cmc Author

ICON

UK
Not specified; competitive within each country; va...
Module 3 ctd document authoring
Pharmaceutical or cro industry experience
Global regulatory requirements knowledge
ICON plc is a world-leading healthcare intelligence and clinical research organization seeking a Senior Manager for Regulatory Affairs CMC

Job Summary

  • ICON plc is a world-leading healthcare intelligence and clinical research organization seeking a Senior Manager for Regulatory Affairs CMC.
  • The role involves authoring Module 3 CTD documents, participating in strategic discussions, and ensuring compliance with global regulatory requirements.
  • The company offers a competitive salary, diverse benefits including health insurance and retirement planning, and a commitment to an inclusive culture.

Matching Summary

ICON plc is a world-leading healthcare intelligence and clinical research organization seeking a Senior Manager for Regulatory Affairs CMC.

Salary

Not specified; Competitive within each country; Various annual leave entitlements; Health insurance offerings; Retirement planning offerings

Skills & Requirements

Must-have

  • Module 3 CTD document authoring
  • Pharmaceutical or CRO industry experience
  • Global regulatory requirements knowledge

Nice-to-have

  • Peptides and proteins modality expertise
  • Strategic discussion participation
  • Strong presentation skills

Key Requirements

  • In-depth proven regulatory affairs expertise
  • Experience with marketing authorization applications
  • Direct regulatory agency interaction experience

Work Rights

Not specified

Tailored Resume

Cover Letter