Senior Scientist – Regulatory Affairs

05 Sep, 2022

Jobs

Senior Scientist – Regulatory Affairs

Systems Planning and Analysis, Inc. (SPA)
Lorton, VA

Overview

Systems Planning and Analysis, Inc. (SPA) is a well-established and progressive defense contracting company in the DC Metro area.  We are a professional services firm established in 1972 that has a long-standing reputation for unrivaled technical and analytical support to some of the top decision makers in the Federal Sector. We do state of the art work and have a cadre of outstanding professionals on our team.

 

SPA assists the Defense Threat Reduction Agency (DTRA) in developing leading edge technologies to counter weapons of mass destruction (C-WMD) in support of DTRA, and transitioning these technologies to the armed services and SOCOM. SPA provides expertise across the full range of chemical, biological, radiological, nuclear, and high-yield explosives (CBRNE) WMDs, Counter-Improvised Threat (CIT), and Countering Threat Network (CTN) technologies to support understanding, detection, identification, characterization, denial, control, disabling, defeating, disposing, safeguarding the force, managing consequences, and test and evaluation in support of military and civilian operations.

Responsibilities

Serve as a regulatory expert to support MCM development programs nearing transition at DTRA JSTO. The candidate will join JSTO Regulatory Affairs Partners (JRAP) group, a team of seasoned experts specialized in regulatory affairs, to provide direct contracted regulatory focused subject matter expertise support to DTRA/JSTO programs. JRAP’s regulatory responsibilities include the following:

(1) Advise, assist and support JSTO programs in the development of robust regulatory strategies;

(2) Provide advice, assistance and support toward the transition of quality programs and products from JSTO to advanced developers such as Medical Countermeasure Systems (JPM-MCS), the Biomedical Advanced Research and Development Authority (BARDA), or industry; and,

(3) Forge a seamless and transparent communication and document-sharing portal with the Transition Partner.

Qualifications

Required:

  • Master’s degree in Biology or a related field.
  • 10 years of experience in regulatory affairs related to drug and device development for products regulated by the FDA.
  • Expertise in non-clinical pharmacology, toxicology, and FDA product development.
  • Strong understanding of federal contracting requirements and DoD acquisition practices.
  • Excellent communication skills (oral and writing).
  • Must have an active DoD Secret security clearance with the ability to maintain during time of employment.

Desired:

  • PhD in Biology or a related field.
  • 15 or more years of experience in regulatory affairs related to drug and device development for products regulated by the FDA.
  • Experience in early pre-clinical development through Phase I clinical trials for drugs/biologics and through 510(k) clearance for medical devices.

Job posted: 2022-09-05