Regulatory Affairs Supervisor

Bethesda, Maryland, United States
Oct 26, 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 Associate Director, QA Regulatory Affairs.


  • Manages regulatory activities for products to ensure alignment and compliance with FDA and company policies
  • Manages the QA Regulatory Specialist
  • Compiles 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
  • Interprets FDA guidelines and regulations and interacts with regulatory agencies
  • Provides regulatory guidance and submits regulatory documents supporting clinical trials to investigators, contractors and staff
  • Prepares responses to CMC comments from regulatory authorities
  • Coordinates the shipment of release drug product to clinical sites
  • Processes import permits to support shipments of clinical trial material
  • Tracks the life-cycle of clinical trial material and CFR reserves
  • Processes investigations of product complaints
  • Reviews and approves change controls for regulatory impact and regulatory reports to QA management

  • Must have a Bachelors degree in a scientific discipline (qualifying experience may be substituted for education). Foreign degrees must be evaluated for U.S. equivalency.
  • A minimum of five years job related experience including two years as a supervisor
  • 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
  • Background related to vaccine and biologics CMC (cell banking, upstream or downstream operations, validation, analytical testing, etc.)
  • 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

  • Knowledge of quality systems (QA and QC)
  • Experience with the GMP manufacturing of Phase I/II clinical material

  • Career-level experienced professional able to carry out a full range of professional duties working independently with minimal guidance
  • Professional know-how to enhance knowledge and skill base of the organization
  • Contributes to delivery of department goals
  • Uses best practices and knowledge of business issues to improve products or services and suggests variations in approach
  • Devises solutions based on limited information and uses past experience, evaluation, and interpretation to identify solutions or to adapt existing approaches to resolve issues
  • Solves complex problems; takes a new perspective using existing solutions
  • Requires strong multicultural awareness to appropriately deliver messages

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