Regulatory Affairs Director

4 weeks ago

Princeton, New Jersey, United States TK-CHAIN LLC Full time
Job Summary

The Director of Regulatory Affairs will play a key role in ensuring the compliance of our clients' drug development programs with US regulatory guidelines and federal regulations. This individual will be responsible for integrating and applying knowledge of regulatory guidelines and federal regulations to all aspects of our clients' drug development programs, policies, and procedures.

Key Responsibilities
  • Act as liaison between company and FDA for assigned projects
  • Manage all regulatory activities associated with our clients' development projects
  • Coach and direct team to produce excellent work and provide development opportunities for team members
  • Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals
  • Provide guidance to multidisciplinary teams on the content, format, style, and architecture of US submissions
  • Edit and manage the scientific sections of an application against regulatory requirements
  • Assist with the writing, review, and preparation of complex applications
  • Manage the organization, preparation, and review of new ANDAs, amendments, supplements, annual reports, and other regulatory documents and correspondence
  • Perform and manage critical analyses of data and independently develop interpretations and conclusions for discussion/consideration with regulatory management
  • Perform critical reviews of all regulatory submissions, focusing attention on deficient/missing items/explanations
  • Ensure the completeness and accuracy of all regulatory submissions
  • Responsibility for the planning, preparation, and submission of regulatory documentation according to planned timing
  • Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs
  • Provide training on applicable requirements for regulatory and scientific staff as required
  • Develop regulatory strategies for assigned projects by analysis of guidances and assessment of similar drug development scenarios
Requirements
  • Advanced degree in a life science
  • Minimum of 12 years of pharmaceutical industry experience, at least 10 of those years in Regulatory Affairs
  • Must have at least 6 years of managerial experience
  • Exhibits excellent written, verbal, and negotiation skills
  • Must be able to effectively articulate and negotiate complex project-related matters to FDA
  • Advanced understanding of pharmaceutical development and CMC regulatory affairs, including regulatory guidelines, federal regulations, and legal considerations
  • Strong ability to prioritize, multi-task, and work in a very fast-paced and dynamic environment
  • Strong critical and logical thinker with ability to analyze problems
  • Highly organized and self-motivated
  • Demonstrated successes at developing fully functional regulatory teams
  • Able to exercise sound judgment
  • Demonstrated ability to make sound decisions on regulatory activities, strategies, and work outputs
  • Unyielding predisposition to detail, accuracy, and clarity

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