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QA Regulatory Affairs Specialist III

Job ID: req1458
Employee Type: exempt full-time
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 Position Overview:

PROGRAM DESCRIPTION

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its’ mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and other bio-therapeutics to address infectious diseases of global significance (HIV-AIDS, Influenza, Ebola, Zika, Malaria and Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility engaged in GMP manufacture, testing, release and supply of Phase I /II clinical products for investigational use in the US and worldwide.

KEY ROLES/RESPONSIBILITIES

Reporting to the QA Regulatory Affairs Supervisor the QA Regulatory Specialist will perform tasks within regulatory affairs consisting of, but not limited to, the following:

  • Draft in eCTD format Chemistry, Manufacturing and control (CMC) documentation required for Investigational New Drug (IND), and Drug Master Files filed with the FDA or other regulatory agencies, using batch records, quality control test reports and SOPs
  • Prepare amendments to CMC sections
  • Interpret FDA guidelines and regulations with guidance from management
  • Participate in interactions with regulatory agencies on defined matters and during inspections
  • Assist team by providing regulatory guidance to investigators, contractors and staff
  • Prepare responses to CMC comments from regulatory authorities
  • Prepare and submit to the client for approval regulatory documents supporting clinical trials 
  • Coordinate the shipment of release drug product to clinical sites
  • Process import permits to support shipments of clinical trial material
  • Track the life-cycle of clinical trial material and CFR reserves
  • Process investigations of product complaints
  • Review and approve change controls for regulatory impact  
  • Revise SOPs for process improvements
  • Draft and provide regulatory reports to QA management

BASIC QUALIFICATIONS

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 in a scientific discipline according to the Council for Higher Education Accreditation (CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
  • In addition to education requirement, a minimum of five (5) years job related experience, or a minimum of three (3) years of experience in a cGMP environment
  • Experience with technical writing or compiling of the CMC section of INDs for vaccines and biologics  
  • Working knowledge of FDA and international biologics/drug regulations
  • Working knowledge of regulatory initiatives including ICH, USP and other regulatory intelligence sources
  • Previous experience in GCP, GLP, or GMP regulated environment
  • Working knowledge of Microsoft Office
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Combination of QA and QC or manufacturing experience
  • Working knowledge of quality systems
  • Experience with the GMP manufacturing of Phase I/II clinical material
  • Background in a functional discipline related to vaccine and biologics CMC (cell banking, upstream or downstream operations, validation, analytical testing, etc.)

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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