Director of Regulatory Affairs- Strategy

1 day ago

Saint Paul MN United States Beacon Hill Staffing Group, LLC Full time
Beacon Hill Staffing Group, LLC - Director of Regulatory Affairs - Strategy

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/or 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 already in non-clinical and/or clinical studies. This position will also 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, primarily the Food and Drug Administration and Health Canada, although the position will rely on the Canadian RA staff for country-specific regulations.

The Director of Regulatory Affairs will directly participate in project teams managing key projects, regulatory deliverables, prioritization, strategy, providing guidance, and tracking regulatory processes. The Senior Manager is expected 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.
  • 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 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 summary reports.
  • Preparing for and executing Health Authority meetings.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

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