Regulatory Affairs Manager
TASC - Frederick, MD

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TASC Infrastructure Protection & Security Business Unit (IPSBU) is seeking a qualified Regulatory Affairs Manager for support to Joint Program Executive Office (JPEO) contract specifically the Medical Domain shall assist in the organization, planning, assessment, and management of regulatory affairs (i.e., FDA) and quality assurance activities to support the research, development, and acquisition of JPEO-CBD medical systems. This support includes, but is not limited to, the following:

Participating on IPTs

Preparing, reviewing, and coordinating regulatory documentation; researching, troubleshooting, and communicating solutions to resolve technical issues related to regulatory documentation; and ensuring that regulatory documentation is compliant and consistent within the DoD Acquisition Framework

Supporting development of POM recommendations and Congressional and Office of the Secretary of Defense briefings

Maintaining relationships with the FDA and other Federal agency personnel, as necessary

Providing coordination and staff support for regulatory, pharmaceutical, and portfolio integration chiefs

Required skills

Education: Successful completion of a full course of study in an accredited college or university leading to a Master’s Degree in Engineering, Science, Business, or a related discipline, is required. DAU Level III certification in PM, SPRDE, or the civilian equivalent, is preferred. A combination of a Bachelor’s Degree in Engineering, Science, Business, or a related discipline, DAU Level III certification in PM or SPRDE, and eight (8) years of experience may be substituted for a Master’s Degree.

General Experience: Eight (8) years of general experience and five (5) years of experience in a program office or similar organization

Required Skills

This is a contingent position based on the award of the JPEO contract.

****This position is located at Ft. Detrick****

TASC is an Equal Opportunity Employer committed to hiring and retaining a diverse workforce. U.S. citizenship is required for most positions.

Required Experience

TASC - 15 months ago - save job - block
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Founded in 1966, TASC, Inc., helps solve complex national security and public safety challenges by providing advanced systems engineering,...