Regulatory Affairs Expert for Clinical Trials

hace 2 semanas


Ciudad de México, Ciudad de México ICON plc A tiempo completo

At ICON plc, we're seeking a skilled Senior Regulatory Affairs Specialist with experience in clinical trials to join our team.

This role will play a pivotal part in ensuring regulatory compliance and facilitating the successful execution of clinical trials, contributing to the advancement of innovative treatments and therapies.

The estimated salary for this position is approximately $80,000 - $110,000 per annum, depending on location and experience.

Job Description:

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.
  • Collaborating cross-functionally to support regulatory aspects of clinical trial planning and execution.
  • Management of activities associated with obtaining initial, amendment and other central authority approvals.
  • Ensuring that IP labels are in adherence to country requirements and submitted where applicable.
  • Provide consultancy to the client on any country-specific issues.
  • Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs.
  • Adaptation of Informed Consent Form according to local regulations.
  • Provide mentoring and training to other entry-level positions if needed.

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.
  • 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:

  • Various 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, subsidised travel passes, health assessments, among others.

Diversity and Inclusion:

We are committed to providing an inclusive and accessible environment for all candidates. We welcome applications from diverse backgrounds and perspectives. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, please let us know or submit a request here.


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