Regulatory Associate (NCI) (647884)

  • 02/19/2018

Job Description



Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.


The Regulatory Associate II (RA II) provides review of and completes submissions for Investigational New Drug (IND) Investigational Device Exemption (IDE) applications, and Drug Master Files (DMFs) to the Food and Drug Administration (FDA) as described in 21 CFR 312, 21 CFR 812, and 21 CFR 314.420. This effort supports the Center for Cancer Research (CCR) Office of Regulatory Affairs (ORA) for the development of clinical protocols by CCR Principal Investigators and compliance with applicable regulations governing human subjects research. The incumbent reviews, assembles, edits, indexes, and submits INDs, IDEs, MFs, and amendments using the electronic Common Technical Document (eCTD) format and complying with FDA requirements and regulations.


  • Develops regulatory and project management strategies for review, preparation, approval, and submission of documents to the FDA
  • Works to develop and modify methods/techniques for solving problems
  • Provides regulatory guidance to clinical investigators and other staff, in collaboration with the IND Manager and Regulatory Affairs Director
  • Coordinates activities pertaining to the compilation and submission of original IND/IDE applications and MFs for management and stakeholder review
  • Requests, reviews, and compiles materials for IND/IDE/MF amendments, such as annual reports, safety reports, CMC information, and other documents required for the life-cycle maintenance of these applications
  • Formats, compiles, and publishes documents for submission in eCTD format
  • Submits to the FDA all CCR regulatory applications, amendments, and supplements in eCTD format in a timely manner as required
  • Uses quality management system software to track eCTD submissions and generate reports for delivery to the CCR as requested
  • Researches reports, regulations, guidelines, databases, internal policies, etc., as appropriate in response to regulatory inquiries from internal and external sources
  • Reviews and/or assists with project development updates, standard operating procedures, and work instructions for regulatory processes
  • Assists in the multi-disciplinary review of clinical research study documents as necessary



To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/health/medical. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • In addition to education requirements, a minimum of two (2) years of progressively responsible experience in biomedical research including a minimum of one (1) year directly related to regulatory management of multiple clinical trials

Additional Required Skills/Experience:

  • Ability to function independently within a team to build strong relationships with multiple groups with an understanding of project management, data collection/requirements, regulatory and quality assurance procedures, and ICH guidelines
  • Demonstrated knowledge of clinical trial concepts and practices, and project management and implementation
  • Must be detail-oriented and possess strong organizational/planning skills and the ability to prioritize multiple tasks/projects
  • High-level proficiency with Microsoft Office Suite and Adobe Acrobat
  • Experience with eCTD software and processes
  • Ability to communicate effectively orally and in writing with non-technical and technical staff
  • Must be well versed in FDA regulations (21 CFR and GCPs)
  • Must be able to obtain and maintain a security clearance


Candidates with these desired skills will be given preferential consideration:

  • Previous experience in regulatory affairs, pharmaceutical drug development or life sciences
  • Regulatory Affairs Certification
  • Advanced degree

Leidos Overview:
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems Global Solutions business (IS GS). For more information, visit The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer. JBLeidos ICJBMeta