The Regulatory Affairs Assistant supports and assists Regulatory Affairs personnel with collection and preparation of submissions to the FDA Center for Tobacco Products related to novel tobacco products intended to reduce exposure to harmful constituents. The Regulatory Affairs Assistant assists with preparation of responses to regulatory agency questions, organizes regulatory information resources and tracks and controls regulatory submissions.
Reports to Regulatory Affairs Specialist
Duties and Responsibilities:
Coordinates, compiles and organizes basic information necessary for the preparation of regulatory submissions
Assists in drafting regulatory submissions for novel tobacco products
Reviews documentation for accuracy, completeness and compliance with applicable regulations and requirements
Cooperates in the archiving of all regulatory documents to ensure safe storage and accessibility
Monitors submissions to ensure adherence to established or proposed timelines
Under supervision of Regulatory Affairs Specialist, investigates issues identified during reviews, obtaining additional information and documentation as necessary
Maintains current knowledge of tobacco product regulations and stays abreast of changes in federal regulations
Researches, develops and recommends submissions strategies
Assists in hosting FDA and other regulatory audits
Work Environment and Conditions:
This position may require the employee to spend long hours reviewing documents and using office equipment and computers.
This position can involve lifting multiple volumes each weighing approximately 5 pounds.
Travel up to 1/4 time may be necessary.
Education: Bachelor's Degree, preferably in a technical (life science, medical technology, engineering) or regulatory field
Experience: Minimum of 2 years in an FDA-regulated industry
Language: Fluent in English, strong verbal and written communication skills
Good computer skills including knowledge of Microsoft Office
Ability to work independently with minimal supervision and as part of a small team