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Summary of Position

The Director of Regulatory Affairs is responsible for Regulatory Affairs dossiers and associated regulatory affairs compliance and operations activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation and submission of electronic drug, biologic, and device applications. The focus of this position is: to lead new submissions associated with the chemistry of new chemical entities (NCE) as well as products already being testing in non-clinical and or clinical studies and 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 heads 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 Director would lead project teams managing key projects, regulatory deliverables, prioritization, strategy and tracking regulatory process. The Director should be able to 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 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.
• Present to upper management at required intervals and effectively communicate successes and challenges.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Requirements

• Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities
• Fifteen or more years of relevant experience in the Regulatory Affairs pharmaceutical industry.
• Five or 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 summary reports.
• Preparing for and executing Health Authority meetings.

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