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QA Regulatory Affairs Specialist

Employer
Frederick National Laboratory for Cancer Research
Location
Frederick, MD, USA
Start date
Dec 22, 2018

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Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital
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Job Details

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.

KEY ROLES/RESPONSIBILITIES

THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL
  • 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

BASIC QUALIFICATIONS
  • 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

PREFERRED QUALIFICATIONS
  • 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)

Company

A rewarding career with global impact

Whether you’re an expert in your field or just starting out, we have a career opportunity for you. We’re always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.

Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.

We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.

Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.

Discover why joining the Frederick National Laboratory team could be the most important career step you take

 

 

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Company info
Website
Phone
301-846-1000
Location
8560 Progress Drive
 Frederick
MD
21701
US
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