Regulatory Affairs Scientist in Frederick, MD at Booz Allen Hamilton Inc.

Date Posted: 7/11/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Frederick, MD
  • Job Type:
    Science
  • Experience:
    Not Specified
  • Date Posted:
    7/11/2018

Job Description

Job Number: R0032486

Regulatory Affairs Scientist

Key Role:

Serve as a core member of integrated product teams (IPTs) and identify regulatory issues and obtain input from other regulatory SMEs. Assist with clinical and nonclinical protocol development and review. Provide guidance and regulatory strategy to IPTs on the development of contract documents and statements of work for the development of medical devices, drugs, or biologic products. Coach IPTs on the conduct of meetings. Provide regulatory assessment, consult, and regulatory opinions on medical devices, drugs, and biologics. Serve as a POC for the FDA and regulatory staff of external collaborators. Comprehend and apply good clinical practices (GCPs), good laboratory practices (GLPs), and good manufacturing practices (GMPs) or quality systems regulations (QSRs) compliance for medical devices.


Basic Qualifications:

-Experience with medical product development and Office of Health and Human Services (HHS)' regulatory processes

-Experience as a regulatory scientist or representing a sponsor

-Experience with medical product development, including pharma and vaccines, GMP, GLP, and GCP

-Experience with Microsoft Word, Excel, and PowerPoint

-Ability to obtain a security clearance

-BA or BS degree in Biomedical Science


Additional Qualifications:

-Experience with clinical training, generation of vaccine candidates, and testing of vaccine candidates in animals and humans preferred

-Experience with establishing and maintaining vaccine INDs, including chemistry, manufacturing, and controls sections, pharmacology and toxicology sections, clinical sections, and annual reporting

-Experience with regulatory requirements pertaining to the manufacture and use of investigational new biologics or vaccines and the safety and welfare of human subjects

-Experience with involving management, coordination, monitoring, or providing evaluation support to a clinical trials program, research study, or research project

-Experience with the review or evaluation of investigational new drugs or new drug applications

-Experience in HHS regulations, including the evaluation of compliance with protocol and regulatory requirements and the safety and welfare of subjects

-Ability to travel to clinical sites and conferences

-Possession of excellent oral and written communication skills


Clearance:

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

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