.Senior Regulatory Affairs Specialist with Experience in Clinical Trials - Mexico City - Office with FlexICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.JR123070Senior Regulatory Affairs Specialist with Experience in Clinical TrialsSite: Mexico CityOffice with Flex: 3 days at office and 2 days at homeWe are currently seeking a Senior Regulatory Affairs Specialist to join our diverse and dynamic team. As a Senior Regulatory Affairs Specialist at ICON, you will play a pivotal role in ensuring regulatory compliance and facilitating the successful execution of clinical trials, contributing to the advancement of innovative treatments and therapies.What you will be doingLeading 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 i.E. Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other central authorities.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.Your profileBachelor'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.What ICON can offer you:Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family