Clinical Trials Regulatory Affairs Specialist with Expertise in Global Compliance
hace 9 horas
We are seeking a seasoned Clinical Trials Regulatory Affairs Specialist to join our team at ICON plc, a world-leading healthcare intelligence and clinical research organization. Located in Mexico City, this role offers a unique blend of work flexibility and professional growth opportunities.
About the Role:The successful candidate will play a pivotal part in ensuring regulatory compliance and facilitating the execution of clinical trials, contributing to the advancement of innovative treatments and therapies.
- Prepare, submit, and maintain regulatory documents for clinical trials, adhering to global standards and regulations.
- Provide expert guidance on regulatory requirements and standards to internal teams, fostering collaboration and knowledge sharing.
- Engage with regulatory agencies to address inquiries, submissions, and approvals, ensuring seamless communication.
- Stay updated on changes in regulations and guidelines to ensure compliance and mitigate potential risks.
- Cross-functionally collaborate to support regulatory aspects of clinical trial planning and execution, driving project success.
To be successful in this role, you will require:
- Bachelor's degree in a scientific or related field; an advanced degree is preferred.
- A minimum of 2 years of experience in regulatory affairs within the pharmaceutical or biotech industry, with expertise in Clinical Trials.
- Strong knowledge of global regulatory requirements and guidelines for clinical trials.
- Demonstrated ability to manage regulatory submissions and interactions with regulatory agencies.
- Excellent communication, attention to detail, and problem-solving skills.
- Advanced English language proficiency for reading, writing, and speaking.
At ICON, we prioritize diversity, inclusion, and belonging, recognizing that our rich diversity drives innovation and better serves our people, patients, customers, and communities. We offer a competitive salary and a range of benefits, including various annual leave entitlements, health insurance options, retirement planning offerings, and more. If you're passionate about regulatory affairs and clinical trials, and value a dynamic work environment, we encourage you to apply.
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