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NCRAF's Spring Summit will have a return engagement by

Dr. Robert Califf

former FDA Commissioner


May 18, 2017

details to come.


RAC EU online Workshop

Register for the self-paced course starting Feb. 7, 2017 

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ECTD Group Meetings

These meetings have resumed as quarterly get togethers for 2017

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Job Postings


Date Posted



  2/17/2017 The Talent Solution VP Regulatory Affairs -
In Vitro Diagnostic (IVD) Devices
  A medical device company and a leader in developing advanced diagnostics technologies, is growing and looking for a hands-on VP of Regulatory Affairs with profound experience and knowledge in In-Vitro Diagnostic Devices. The VP RA will be responsible to all procedures and communications for obtaining US FDA clearance.
  1/25/2017 Quintiles Regulatory Affairs Manager

Manages a regulatory and/or technical project, for both internal and external clients, as appropriate. Provides strategic regulatory and/or technical consultancy on a variety of projects.

 • Acts as a Lead Regulatory Professional on any type of writing or technical project, with limited guidance from senior staff using experience and initiative to generate new and unusual document types to meet customer requirements.

 • Provides strategic regulatory and/or technical consultancy on a variety of projects and provides senior review and guidance for most documents prepared by junior colleagues.

 • May act as a Project Manager for a stand-alone project, with full project management responsibility.

 • May prepare a single service regulatory or technical proposal for senior review and/or propose budgets for less routine projects, out of scope activities and potential budget efficiencies. Deliver business development presentations to customers with confidence and detailed knowledge, as directed.

 • Independently meet with customers face to face to discuss project status. Identifies creative solutions to challenges that are acceptable to Quintiles and customers, thereby consistently receiving positive customer feedback.

 • Ensures compliance with regulatory processes, ensuring readiness for internal or external project audits.

 • May design training materials and deliver training externally and internally.

 • May represent region or site on a regulatory, technical or cross functional Initiative.

 • Performs other tasks or assignments, as delegated by Regulatory management.

JobID: 1625131

  1/25/2017 Inc Research Regulatory Consultant

Responsible for contributing to preparation of regulatory submissions for conduct of clinical trials, product registration, and post approval maintenance activities; participates on project teams. Responsible for day to day contribution to projects. Understands allocated project hours and tracks compliance. Monitors personal utilization. Interacts with internal personnel and technical experts on projects. Interacts with clients under guidance. Conducts regulatory research on projects as needed. Attends client meetings. Retrieves literature references as needed. Contributes to preparation of regulatory submissions for conduct of clinical trials, product registration, and post approval maintenance activities; participates on project teams. Participates in quality improvement efforts to increase overall operational efficiency.  

JobID: 16004051

  1/20/2017 Vanderbilt University Research Regulatory Affairs Manager

  Serves as the central resource to investigators to assist and provide guidance regarding Investigational New Drug (IND) development through experience with and knowledge of related federal regulations (FDA). Works closely and partners with investigators and internal departments to deliver safe and effective research designs for clinical trials in line with institutional policies and procedures and federal regulations. Provide quality assurance support with focus on compliance with methods, facilities and controls as they relate to federal regulations. Serve as a resource to investigators to assist and provide guidance and education regarding device development through experience with and knowledge of related federal regulations.

JobID: 1510506

  1/18/2017 RTI International Regulatory Affairs Specialist

  RTI International is currently seeking a Regulatory Affairs Specialist with a background and interest in drug development. The successful candidate will support project activities related to the development of new drugs to treat neglected diseases and for other unmet medical needs. The primary responsibility of this position will be to provide regulatory support to the Regulatory Affairs Lead. These tasks could include writing, formatting, compiling and maintaining supporting documentation/technical files in support of routine and complex regulatory submissions to the FDA. This position is located in the Research Triangle Park area of NC.

JobID: 17751

  12/8/2016 UNC Lineberger Cancer Center Regulatory Affairs Manager 

  The Regulatory Affairs Manager is responsible for performance management of the Lineberger Comprehensive Cancer Center (LCCC) Clinical Protocol Office Regulatory Staff. This supervisory role is comprised of staffing, work assignment, implementing the performance management program, supporting staff learning and development, leave management and schedules, and HR-related functions. This position is also responsible for the development and implementation of Regulatory Standard Operating Procedures. These responsibilities relate to the mission of the UNC/LCCC Protocol Office by addressing the regulatory compliance, thereby ensuring the quality of research and institutional integrity. Extensive knowledge of Federal Regulations required. CCRP, CCRC, CIRB or RAC Certification preferred.

JobID: 20018256

  11/18/2016 Novan Regulatory Affairs Manager

  The Regulatory Affairs Manager will work in close collaboration with line management and cross-functional project teams to develop and implement regulatory strategies and coordinate regulatory submissions, including nonclinical, clinical, and CMC. Working with internal scientific and technical departments as well as external vendors, the Regulatory Affairs Manager will be responsible for the preparation and submission of all regulatory documents, management of submission processes, and oversight of various regulatory tracking tools, timelines and infrastructure. In addition, this role will provide regulatory guidance to all departments and project teams.

Principal Responsibilities and Accountabilities: 1. Participate as Regulatory Affairs representative on assigned projects, and assist R&D teams by providing regulatory guidance and information across all relevant areas including nonclinical, clinical, and CMC. 2. Oversee and manage regulatory operations; collaborate with project teams to author and publish regulatory submissions, including formatting and compilation of paper and electronic submission documentation, and file by required due dates and in accordance with applicable regulations and guidelines. 3. Author documents for submission, including regulatory agency correspondence, documents for INDs and NDAs, and meeting briefing packages, and review and provide regulatory comments and advice for documents prepared by other departments. 4. Ensure documents for submission are in compliance with current regulations and guidance. 5. Provide regulatory assessment of manufacturing processes and changes, determine impact of changes on regulatory filings, and prepare appropriate IND amendments and NDA supplements. 6. Manage and track regulatory queries from regulatory agencies and collaborate with subject matter experts to provide written responses to questions. 7. Contribute to the review, implementation, and maintenance of the submission process and provide suggestions for ongoing process improvement. 8. Prepare for and participate in regulatory audits and inspections. 9. Maintain awareness of industry and regulatory developments and provide updates to regulatory and project teams.

  11/17/2016 FPC of Raleigh Executive Search Regulatory Affairs Manager

  This rapidly expanding and well-funded clinical stage pharma is seeking a Sr. Regulatory Affairs associate already based in the RTP, NC, area who is ready to take the next step up into a Manager of Regulatory Affairs role and thrives in a fast paced environment. This role would also get involved in regulatory affairs in a variety of therapeutic ares. Must have experience with managing/reviewing regulatory documentation (like IND filings or clinical regulatory documentation). Working with external contractors and other regulatory consultants (publishers, etc.) and RAC certification a plus. BS degree/MS/Ph.D. Preference for 5+ years of pharma industry experience (CRO or pharma). Candidates must already be based in the RTP area (no relocation assistance is available).

Contact Joanne Gehas at