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Regulatory Assistant

Company Name:
Pace Analytical Services Inc
Regulatory Assistant - Gaithersburg, MD (
washington
DC)
Summary
Pace Analytical is seeking a Regulatory Assistant to join our operation in the Gaithersburg, MD/Washington DC area. The Regulatory Assistant supports the global enzyme regulatory affairs department in the animal health division of a large pharmaceutical company. The regulatory tasks involve assisting with, organizing and responding to regulatory requests, such as obtaining outside documents, and maintaining organized files for all regions and for all products. The person selected for this
position
must be a team player.

Responsibilities
Assist with organizing and responding to regulatory requests such as obtaining outside documents and maintaining organized files for all regions and for all products.
Maintain the US, Europe, and Emerging Markets regulatory files.
Coordinate with internal departments, state agriculture departments, FDA, and outside audit companies to obtain documents required for international registrations.
Assist in compiling technical regulatory documents to support Emerging Market submissions.
Coordinate with outside service providers to have documents legalized for the appropriate jurisdictions.
Conduct other special tasks as requested.
Requirements
Bachelor's degree in animal science, regulatory or related field.
0-2 yrs of regulatory or health care related industries.
Ability to manage multiple projects simultaneously and meet deadlines.
Excellent organizational and communication skills (both oral and written).
Demonstrated technical skills with MS Office (MS Word & Excel).
Familiarity with database systems is a huge plus.
Candidates must be a team player.

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