Beacon Hill Staffing Group, LLC - Director of Regulatory Affairs - Strategy Location: Columbus, Ohio
Summary of Position: The Director of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. Responsibilities include defining and authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation of electronic submissions. The main focus will be on new submissions associated with new chemical entities (NCE) as well as products in non-clinical and/or clinical studies. A secondary focus will be on existing marketed products or those obtained through acquisition.
This position will facilitate key regulatory projects requiring 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. The regional focus for project deliverables is North America, specifically the Food and Drug Administration and Health Canada, while relying on Canadian RA staff for country-specific regulations.
Essential Functions:
Manage submissions and projects as assigned by Regulatory leadership assuring compliance, planning, and execution.
Represent regulatory on cross-functional teams.
Process, interpret and provide recommendations for complex strategies.
Provide regulatory and technical expertise to cross-functional teams.
Critically review documentation for regulatory submissions and provide input for necessary revisions.
Contribute to defining Target Product Profile and build compliant drug 'approvable' dossiers and registration.
Serve as Liaison for third-party service providers.
Maintain associated database for tracking individual and department project deliverables for regulatory submissions and milestones.
Develop and implement policies, procedures, practices, and strategies for Regulatory Affairs, based on current Health Authority guidelines and regulations.
Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis and execute solutions.
Execute objectives in alignment with Regulatory leadership, Marketing, and Global Business Units.
Communicate regulatory governmental policy changes to management in a timely manner and provide plans for meeting and complying with new requirements.
Support the professional development of regulatory staff through mentorship and guidance.
Present to upper management at required intervals and effectively communicate successes and challenges.
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:
Regulatory Strategy experience.
Bachelor of Science in Chemistry, Pharmacy, Biology, or other life science, plus direct experience managing regulatory activities.
Twelve or more years of relevant Regulatory Affairs experience.
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