Regulatory Affairs Lead for Clinical Trials

hace 3 semanas


Xico, México Icon Plc A tiempo completo
About ICON Plc

ICON Plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment that drives innovation and excellence, where we welcome talented individuals to join our mission in shaping the future of clinical development.

Salary Information

We offer a competitive salary ranging from $80,000 to $120,000 per year, depending on experience and qualifications.

Job Description

We are seeking a Senior Regulatory Affairs Specialist to play a pivotal role in ensuring regulatory compliance and facilitating the successful execution of clinical trials. As a key member of our team, you will contribute to the advancement of innovative treatments and therapies.

  • 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.
  • Collaborating cross-functionally to support regulatory aspects of clinical trial planning and execution.
Required Skills and Qualifications

To be successful in this role, you should have:

  • 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.
  • Desirable: e-systems knowledge on CTMS, PhlexEview, PSO, BOX.
Benefits

We offer a range of benefits to support your well-being and work-life balance, including:

  • Varying annual leave entitlements.
  • 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.
  • Global Employee Assistance Programme, TELUS Health, 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.
Why Choose ICON Plc?

We are an equal opportunity and inclusive employer committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.



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