Regulatory Affairs Expert with Strong Clinical Trials Background

hace 4 días


Ciudad de México, Ciudad de México ICON A tiempo completo

At ICON, we are seeking a Senior Regulatory Affairs Specialist to join our team in Mexico City.

The ideal candidate will have a strong background in clinical trials and regulatory affairs, with experience in preparing and submitting regulatory documents.

We offer a competitive salary of $95,000 per year, plus benefits such as annual leave entitlements, health insurance, and retirement planning options.

Job Description:

The Senior Regulatory Affairs Specialist will be responsible for leading the preparation, submission, and maintenance of regulatory documents for clinical trials. This will involve providing expertise and guidance on regulatory requirements and standards to internal teams.

The successful candidate will also be required to interface with regulatory agencies to address inquiries, submissions, and approvals. Additionally, they will need to monitor changes in regulations and guidelines to ensure compliance and mitigate risks.

Required Skills and Qualifications:

  • 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.
  • Strong knowledge of global regulatory requirements and guidelines for clinical trials.
  • Proven ability to manage regulatory submissions and interactions with regulatory agencies.
  • Excellent communication, attention to detail, and problem-solving skills.
  • Advanced English for Reading / Writing / Speaking.

Benefits:

  • Annual leave entitlements.
  • Health insurance.
  • Retirement planning options.
  • Global Employee Assistance Programme, LifeWorks.
  • Life assurance.
  • Flexible country-specific optional benefits.

Company Overview:

ICON is a world-leading healthcare intelligence and clinical research organization. We are proud to foster an inclusive environment driving innovation and excellence.


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