Regulatory Affairs Director

3 days ago


Santa Clara, California, United States Thrive Full time
Associate Director- CMC Regulatory

Thrive is seeking an experienced Associate Director to lead our CMC Regulatory team. As a key member of our organization, you will be responsible for providing regulatory strategies and plans for CMC related submissions, providing regulatory leadership to CMC project teams, and ensuring regulatory milestones are met to support regulatory approval strategies and overall business goals of the company.

Key Responsibilities:
  • Develop and implement regulatory strategies and plans for CMC related submissions
  • Provide regulatory leadership to CMC project teams, ensuring timely and high-quality submissions
  • Assist with the authoring of CMC related submissions, including INDs, NDAs, and MAAs
  • Manage workflow from authoring to approval in document management system
  • Coordinate publishing efforts to meet deadlines and high-quality standards
  • Ensure regulatory milestones are met to support regulatory approval strategies and overall business goals of the company
  • Plan and lead meetings with Regulatory Agencies on assigned projects
  • Define content, communicate, and direct the organization in preparation of high-quality and effective regulatory submissions
  • Maintain knowledge of pertinent regulations and guidances, interpret developments, and provide recommendations to the project team and senior management team
  • Recommend regulatory procedures and practices to assure adherence to regulatory requirements
  • Review change controls and provide a regulatory assessment based on Agency guidances
Requirements:
  • Bachelor's or Master's degree in a life science or relevant discipline required; RAC certification preferred
  • 10+ years of in-depth regulatory experience in pharmaceutical and/or biotech development
  • Experience with regulatory submissions and requirements, including documents required for INDs, NDAs, and MAAs, supplements, and briefing documents
  • Knowledge of FDA and Part 312 and 314
  • Knowledge of document management system
  • Knowledge and utilization of regulations and guidances
  • Excellent team interaction skills and ability to work successfully in cross-functional teams
  • Ability to work in a dynamic environment with high degree of flexibility
  • Independent management of projects
  • Excellent written and verbal communication skills
  • Knowledge of Canadian and EU requirements preferred


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