Ra Cmc Consultant

ICON plc

Not specified; competitive salary offered; range o...
**
Minimum 7 years regulatory affairs experience
Pharmaceutical or cro industry background
Global regulatory requirements knowledge usa eu japan china
** ICON plc is seeking a Senior Manager, Regulatory Affairs specializing in CMC strategy to join their diverse team. The ideal candidate should have extensive regulatory affairs experience, particularly in drug development, and the ability to interact with regulatory agencies. **

Job Summary

  • ICON plc is seeking a Senior Manager Regulatory Affairs expert to provide strategic CMC support within a world-leading healthcare intelligence organization.
  • The role requires demonstrating advanced understanding of regulatory work across different drug development stages including LCM and major global regions.
  • Candidates will act as trusted partners representing the Regulatory Affairs Department in business development activities while contributing to diverse areas like agency interactions and orphan drugs.

Matching Summary

Match Score: 75

** ICON plc is seeking a Senior Manager, Regulatory Affairs specializing in CMC strategy to join their diverse team. The ideal candidate should have extensive regulatory affairs experience, particularly in drug development, and the ability to interact with regulatory agencies. **

Salary

Not specified; Competitive salary offered; Range of additional benefits including health insurance and retirement planning

Skills & Requirements

Must-have

  • Minimum 7 years regulatory affairs experience
  • Pharmaceutical or CRO industry background
  • Global regulatory requirements knowledge USA EU Japan China

Nice-to-have

  • Experience with peptides and proteins modalities
  • Module 3 CTD document authoring capability
  • Business development and client advisory skills

Key Requirements

  • Minimum 7 years' experience in regulatory affairs
  • Supervisory experience required
  • Direct regulatory agency interaction experience

Work Rights

Not specified

Tailored Resume

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