Senior Regulatory Affairs Specialist

ICON

Not specified; competitive within each country; va...
Hybrid
4+ years clinical trial submissions experience
Fluent english reading writing speaking
Knowledge of anvisa regulatory requirements
ICON is a world-leading healthcare intelligence and clinical research organization seeking a Senior Regulatory Affairs Specialist to join their diverse team

Job Summary

  • ICON is a world-leading healthcare intelligence and clinical research organization seeking a Senior Regulatory Affairs Specialist to join their diverse team.
  • The role involves direct interaction with regulatory authorities like ANVISA and ensuring timely preparation of submission documentation for clinical trials.
  • Candidates will benefit from competitive salary, health insurance, retirement planning, and a global Employee Assistance Programme focused on well-being.

Matching Summary

ICON is a world-leading healthcare intelligence and clinical research organization seeking a Senior Regulatory Affairs Specialist to join their diverse team.

Salary

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

Skills & Requirements

Must-have

  • 4+ years clinical trial submissions experience
  • Fluent English reading writing speaking
  • Knowledge of ANVISA regulatory requirements
  • Experience with DDCM and DEEC submissions
  • Proficiency in CTMS and eTMF systems

Nice-to-have

  • Mentoring junior team members
  • Contributing to system procedure reviews
  • Proactive risk identification skills
  • Process improvement mindset
  • Collaboration across country regions

Key Requirements

  • 4+ years of experience in clinical trial submissions
  • Advanced knowledge of country/region Regulatory Agency requirements
  • Fluent English language proficiency required

Work Rights

Not specified

Tailored Resume

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