Senior Regulatory Affairs Specialist

ICON plc

Competitive salary; benefits include annual leave,...
Hybrid
4+ years clinical trial submission experience
Fluent english communication skills
Knowledge of anvisa and ich-gcp regulations
The role involves completing country and regional Clinical Trial Regulatory deliverables in line with ICON policies and ICH-GCP principles

Job Summary

  • The role involves completing country and regional Clinical Trial Regulatory deliverables in line with ICON policies and ICH-GCP principles.
  • Candidates will interact directly with regulatory authorities like ANVISA and manage the preparation of submission documentation.
  • ICON offers a competitive salary, health insurance, retirement planning, and a global Employee Assistance Programme.

Matching Summary

The role involves completing country and regional Clinical Trial Regulatory deliverables in line with ICON policies and ICH-GCP principles.

Salary

Competitive salary; Benefits include annual leave, health insurance, retirement planning; Not specified

Skills & Requirements

Must-have

  • 4+ years clinical trial submission experience
  • Fluent English communication skills
  • Knowledge of ANVISA and ICH-GCP regulations

Nice-to-have

  • Mentoring junior team members
  • Process improvement mindset
  • Collaborative cross-functional teamwork

Key Requirements

  • 4+ years experience in clinical trial submissions
  • Advanced knowledge of country/region RA requirements
  • Fluent English reading, writing, and speaking

Work Rights

Not specified

Tailored Resume

Cover Letter