Brillient Corporation’s Mission is to Protect, Serve, and Care
for the American people. Brillient’s work in our National Security
Sector, enables the mission to protect the homeland. Our Civilian
Sector projects serve the country with revenue collection,
financing small businesses, assisting citizens recover from
disasters and securing the federal workforce. Our Healthcare Sector
work is focused on care for the American people protecting the
nation’s food supply, ensuring quality medicines, lowering health
costs, and improving quality of care.
Brillient's philosophy is simple – we hire brilliant people and
then get out of their way so they can deliver brilliant outcomes.
Brillient is client-centric, employee-focused growing organization
with a vibrant culture. We aim to bring highly trained
professionals with the most relevant expertise to each project and
are committed to delivering innovative and cost-effective solutions
to our clients.
Are you ready to join this fast-growing, innovative team?
We have an opportunity with FDA for a Regulatory Labeling Senior
Consultant. Read on for details!
The Regulatory Labeling Senior Consultant (Consultant) shall
provide support to the Agency's Product Labeling Group.
Specific tasks shall include, but not be limited to, the
Provide strong strategic guidance on labeling regulations,
requirements, and labeling trends.
Provides labeling negotiations support; draft responses to
queries and revised labeling for submissions; tracks
labeling-related requests and responses.
Prepares the submission ready labeling documents for review by
FDA lead. Maintains and tracks labeling documents as
Monitors regulation and standard changes pertaining to Labeling
Ensure compliance with applicable laws, regulations and FDA
guidelines, as well as internal audit document requirements
Requirements Bachelor's degree with a minimum of 14 years of
specialized experience in operations or management relevant to the
Excellent communication skills (verbal and written) and a
demonstrated proficiency in Microsoft Windows/Office.
Familiar with a variety of the field's concepts, practices, and
Prior experience writing the labeling for a product
Prior experience in submissions
Knowledge of FDA Guidance for medical product labeling,
including PLR guidance and guidance on individual labeling