Summary of Position

The Senior Manager of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs 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 of electronic submissions. This position requires a highly skilled and experienced individual capable of navigating the complex regulatory landscape related to CMC. The main focus of this position will be on new submissions associated with new chemical entity (NCE) with a secondary focus on existing marketed products or those obtained through acquisition.

This position will facilitate the 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. 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 Senior Manager Regulatory Affairs will directly participate in project teams managing key projects, regulatory deliverables, prioritization, strategy, providing guidance, and tracking regulatory process. The Senior Manager is expected to 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 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
• Develop and implement regulatory strategies for CMC aspects of drug development and registration
• Lead the preparation and submission of CMC sections of regulatory documents (e.g., INDs, NDAs, BLAs, MAAs) in compliance with global regulations and guidelines
• 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. Understand and recommend strategies based on current local registration requirements and applicable industry standards
• Supports the professional development of regulatory staff through mentorship and guidance
• 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

Working Conditions :