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Curium Associate Director Regulatory Affairs in Maryland Heights, Missouri

Summary of Position The Associate Director of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities includes, but not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation of electronic submissions. The main focus of this position will be on new submissions associated with new chemical entity NCE as well as products already being testing in non-clinical and or clinical studies. This position will have secondary focus on existing marketed products or those obtained through acquisition. This position will facilitate success of key regulatory projects that may require concept building, Target Product Profile TPP, claims definition, regulatory strategy including non-clinical and clinical, Non-clinical and clinical protocol review, defining dossier Table of contents, submission building, health authority management, obtaining approvals, managing post approval commitments, and product launch. This position will work closely with the regulatory leader heading the Chemistry Manufacturing Controls dossier modules. The regional focus for project deliverables is North America, that is, Food and Drug Administration and Health Canada, although the position will rely on the Canadian RA staff for country specific regulations. The Associate Director would participate on project teams managing key projects, regulatory deliverables, prioritization, strategy and tracking regulatory process. The Associate Director is expected to be able identify risk and make risk based decisions to facilitate solutions for process and submission. The candidate will direct and mentor less experienced staff on Risk Based Decision making. Essential Functions * Manage submissions and projects as assigned by the Senior Director of New Product Development assuring compliance, planning, and execution. * Process, interpret and provide recommendations for complex strategies. * Critically review documentation for regulatory submissions and provide input for necessary revisions. * Define Target Product Profile and build compliant drug and device approvable dossiers and registration. * Serve as Liaison for third party service providers supporting Nuclear Medicine. * Maintain associated compliance database for tracking individual and department project deliverables for New Submissions and RA Compliance. * Implement policies, procedures, practices, and strategies for Regulatory Affairs. * Develop and implement in alignment with regional RA taking local considerations into account. * Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis and execute solutions. * Execute objectives in alignment with Regulatory Head, Marketing and Global Business Units. * Coordinate communication between the Global Business Units and the Regional Regulatory Affairs staff resulting in a collaborative relationship. * Communicate regulatory governmental policy changes to management in a timely manner and provide plans for meeting and complying with new requirements. Understand and recommend strategies based on current local registration requirements and applicable industry standards * Mentor RA staff. * Present to upper management at required intervals and effectively communicate successes and challenges. Requirements * Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities * Seven years of Regulatory Affairs pharmaceutical industry experience. * Two years of supervisory experience of direct reports required, matrix management experience preferred. * Experience in leading new project submission efforts including strategy, compilation, submission, and approval by a health authority. * Experience writing Target Product Profiles, non-clinical studies, reviewing Clinical protocols and sum

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