Regulatory Affairs Scientist, Senior in Falls Church, VA at Booz Allen Hamilton Inc.

Date Posted: 9/11/2018

Job Snapshot

Job Description

Job Number: R0032485

Regulatory Affairs Scientist, Senior

Key Role:

Serve as a core member of integrated product teams (IPTs) and team leader of internal regulatory teams. Review, edit, and coordinate document submissions to the FDA and identify regulatory issues and obtain input from other regulatory SMEs. Aid with clinical and non-clinical protocol development and review and provide guidance and regulatory strategy to IPTs for the development of contract documents and statements of work for the development of medical devices, drugs, or biologic products. Coach IPTs in the conduct of meetings with the FDA. Provide regulatory assessment, consult, and regulatory opinion for medical devices, drugs, and biologics. Serve as a POC with FDA and regulatory staff of external collaborators. Comprehend and apply Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP) or Quality Systems Regulation (QSR) compliance for medical devices.


Basic Qualifications:

-5+ years of experience with medical product development or FDA regulatory processes

-Experience as an FDA regulatory scientist or representing a sponsor before the FDA

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

-Experience with Microsoft Word, Excel, and PowerPoint

-Ability to obtain a security clearance

-MA or MS degree in Biomedical Science


Additional Qualifications:

-Experience with clinical training for the 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 managing, coordinating, monitoring, or evaluating support to a clinical trials program, research study, or research projects

-Experience with Food and Drug Administration (FDA) for the review or evaluation of investigational new drugs or new drug applications

-Experience with Office of Human Research Protections (OHRP) regulations that involved evaluation of compliance for protocol and regulatory requirements and the safety and welfare of human 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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