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Regulatory Labeling Senior Consultant

Company: TC Industries Of Canada Company
Location: Silver Spring
Posted on: September 12, 2020

Job Description:

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 following:

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 appropriate.

Monitors regulation and standard changes pertaining to Labeling requirements.

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 applicable task.

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 procedures.

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 sections

Keywords: TC Industries Of Canada Company, Silver Spring , Regulatory Labeling Senior Consultant, Other , Silver Spring, Maryland

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