QA Regulatory Affairs Specialist

Frederick, MD, USA
Nov 22, 2018
Required Education
Bachelors Degree
Position Type
Full time
The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases. This position reports to the QA Regulatory Affairs Supervisor.


  • 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

  • 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 in regulatory submission preparation in accordance with eCTD format, ICH, and US requirements
  • 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

  • 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)