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Chief Regulatory Science Affairs Program Officer

Winston Salem, NC, USA | Wake Forest

  • Industry:
    Healthcare - Hospitals
  • Position Type:
  • Functions:
    Regulatory Affairs
  • Experience:
    10-12 years
Job Description:
84 people have viewed this job

The Wake Forest Institute for Regenerative Medicine (WFIRM) is recognized as an international leader in translating scientific discovery into clinical therapies. Physicians and scientists at WFIRM were the first in the world to engineer laboratory-grown organs that were successfully implanted into humans. Today, this interdisciplinary team that numbers about 400 is working to engineer more than 40 different replacement tissues and organs, and to develop healing cell therapies – all with the goal to cure, rather than merely treat, disease.


This position will support the expanding pipeline of products in development from a regulatory perspective. This individual will provide leadership and work closely with other areas within the institute.


A strong background in the Regulations for Regenerative Medicine Products including knowledge and understanding of FDA Guidelines and experience interacting with Regulatory Authorities is required.


In this position, the successful candidate will be responsible for driving the development of innovative regulatory strategies.


Responsibilities



  • Leadership regarding clinically relevant research projects, programs, and initiatives.

  • Provide oversight and guidance on compliance with local, federal and international regulations.

  • Serve as a liaison to external organizations, NIH, Hospitals).

  • Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies.

  • Lead and oversee regulatory activities for assigned projects and other applicable requirements to ensure compliance.

  • Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs.

  • Provide interpretation of and advice regarding regulations, directives, and guidance.

  • Represent Wake Forest Institute for Regenerative Medicine in a professional manner, foster a cooperative and team relationship with partner organizations including the RegenMed Development Organization, and the RegenMed Hub.


Qualifications



  • MD or PhD in a scientific discipline preferred, with at least 10 years of experience at the FDA in an applicable position.

  • Knowledge and understanding of regulations and guidelines.

  • Strong attention to detail and the ability to handle multiple tasks.

  • Excellent organizational, computer and documentation skills and an ability to prioritize effectively.

  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.

  • Strong knowledge and interest in the evolving landscape of novel regenerative medicine development programs.

  • Strong problem solver who is highly organized with the ability to thrive in an environment with rapidly changing priorities.

  • Ensure consistency and adherence to good manufacturing practices and regulatory guidelines.

  • Interpersonal Skills: Demonstrates the ability to work well with colleagues and with external organizations.


About Us


Wake Forest Baptist Health and Atrium Health have joined forces in a strategic combination that will enhance care, transform medical education and create economic opportunity for countless lives in North Carolina and beyond. As a part of that combination, the two health systems will be integrating technology and platforms, including our career sites.


This means that although you are applying on the Wake Forest Baptist Health Career Site, you receive communications from the Atrium Health Recruitment Team. Please know that this is an expected process, and thanks in advance for your flexibility.


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