Senior Regulatory Affairs Specialist

hace 2 días


Xico, México Icon A tiempo completo

Job Summary

At ICON, we are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the successful execution of clinical trials.

Key Responsibilities

  • Lead the preparation, submission, and maintenance of regulatory documents for clinical trials.
  • Provide expertise and guidance on regulatory requirements and standards to internal teams.
  • Interface with regulatory agencies to address inquiries, submissions, and approvals.
  • Monitor changes in regulations and guidelines to ensure compliance and mitigate risks.
  • Collaborate cross-functionally to support regulatory aspects of clinical trial planning and execution.

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.
  • 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.

What We Offer

  • A competitive salary and benefits package.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • A Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
  • Life assurance.
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, we are committed to providing a workplace free of discrimination and harassment. We are an equal opportunity and inclusive employer.



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