Regulatory Affairs Manager

3 hours ago


GondrecourtleChâteau, Grand Est, United States Beacon Hill Staffing Group Full time
Job Summary

We are seeking a highly experienced Regulatory Affairs professional to join our team at Beacon Hill Staffing Group. As a Senior Manager of Regulatory Affairs, you will be responsible for leading the development and implementation of regulatory strategies to ensure compliance with US and international regulatory agencies and guidelines.

Key Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with US and international regulatory agencies and guidelines.
  • Lead the development and submission of regulatory documents, including dossiers and registration.
  • Collaborate with cross-functional teams to ensure regulatory compliance and strategy alignment.
  • Provide regulatory expertise and guidance to internal stakeholders.
  • Manage and maintain associated databases 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.
Requirements
  • 12+ years of relevant Regulatory Affairs pharmaceutical industry experience.
  • 2+ 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.
About Us

Beacon Hill Staffing Group is a leading provider of staffing solutions to emerging growth companies and the Fortune 500. We deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success, and a passion for innovation, creativity, and continuous improvement.



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