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Executive Director Regulatory Affairs

1 month ago

Grove City, Ohio, United States Travere Therapeutics, Inc. Full time

{"Department": "Regulatory Affairs", "Location": "USA", "Job Summary": "We are seeking a talented Executive Director to develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease. The successful candidate will ensure fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.", "Responsibilities": ["Develop and recommend strategic and operational regulatory direction and mentorship on projects including the use of regulatory tools in developing accelerated global regulatory approval strategies using novel endpoints, biomarkers or alternative clinical trial data and critical issue management based on current registration requirements and applicable industry standards.", "Develop and execute fast to market regulatory strategies, regulatory requirements for clinical studies, marketing approval, evidence generation and life cycle management.", "Manage interface with outside regulatory agencies and trade associations and act as an advisor/liaison to senior management in order to plan, evaluate and recommend global regulatory strategy.", "Accountable for the preparation, submission and maintenance for product specific dossiers (IND/CTA, NDA/MAA and others as required) per local country requirements with relevant health authorities (e.g. product submissions, correspondence, meeting requests).", "Negotiate with regulatory authorities and respond to regulatory authority queries during the development and review process to ensure submission approval.", "Ensure annual licenses, registrations, listings and patent information are maintained.", "Ensure compliance with product post marketing approval requirements.", "Ensure labeling, publications, advertising and promotional items are compliant with regulatory requirements.", "Assess regulatory impacts associated with changes made in the development of products.", "Collaborate with internal stakeholders (Medical, Clinical, preclinical) and project leadership team to define or develop and obtain registration documents as required to support global development actions.", "Provide leadership with global regulatory strategy teams to ensure development of team members through the sharing of knowledge and expertise on strategic thinking and regulatory precedence reviews.", "Ensure regulatory tools are complaint and kept up to current standards.", "Participate in product development, and acquisition assessment teams to evaluate potential Regulatory Strategies.", "Formulate department procedures, as required.", "Recruit, develop, manage an effective regulatory team and elevate"]