.**JR097624****Regulatory Affairs Specialist****Site: Mexico, Benito Juarez**At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.That's our vision. We're driven by it. And we need talented people who share it.If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.**Overview**:The Regulatory Affairs fulfills the role of Local Regulatory Affairs Lead and is responsible for preparing, submittingand following up on initial and amended Regulatory Agency, Central Independent Ethics Committee (IEC), and any other centralsubmissions required in the country(s) they are responsible for, within contracted timelines and budget, in accordance with local regulatoryrequirements and sound scientific/technical principles, including the creation and modification of documentation required for approval. Is responsible for the provision of information relating to local importation and exportation requirements. Where locally appropriate theymay be responsible to carry out all practical steps to ensure that importation and exportation requirements are met for InvestigationalProduct (IP) and any other clinical trial supplies needed for the trial within their country. The RA is also responsible for providing review ofthe translation into the local language of clinical trial supply labeling to ensure it meets local regulatory requirements. Additionally the RAwill ensure that Insurance Certificates, Country Specific Informed Consent forms and any other patient documentation adheres to countryrequirements. The RA may be responsible for activities related to product registration maintenance.**Responsibilities**:- 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 for the assigned country/ countries.- Management of central/country level submissions associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) the RAS is responsible for.- Ensuring that IP labels are in adherence to country requirements and submitted where applicable.- Management of the central/country level Informed Consent and any other documentation given to patients i.E