Senior Regulatory Affairs Specialist With Experience In Clinical Trials

hace 3 semanas


Xico, México Icon Plc A tiempo completo

Job Title: Senior Regulatory Affairs Specialist With Experience In Clinical Trials

Job Summary:

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ICON plc. As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring regulatory compliance and facilitating the successful execution of clinical trials.

Key Responsibilities:

  • Leading the preparation, submission, and maintenance of regulatory documents for clinical trials.
  • Providing expertise and guidance on regulatory requirements and standards to internal teams.
  • Interfacing with regulatory agencies to address inquiries, submissions, and approvals.
  • Monitoring changes in regulations and guidelines to ensure compliance and mitigate risks.

Requirements:

  • Bachelor's degree in a scientific or related field; advanced degree preferred.
  • Minimum of 2 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
  • Experience in Clinical Trials.
  • Strong knowledge of global regulatory requirements and guidelines for clinical trials.

What ICON Offers:

At ICON plc, we offer a competitive salary and a range of additional benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a global employee assistance programme.



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