The Regulatory Affairs Specialist oversees the design and writing of regulatory submissions to the FDA Center for Tobacco Products related to novel tobacco products intended to reduce exposure to harmful constituents. The Regulatory Affairs Specialist ensures that the submissions are in compliance with FDA requirements, and assists management, manufacturing and marketing personnel in understanding current regulations and proposed and mandated changes.
Reports to Director of Regulatory Affairs
Duties and Responsibilities:
Prepares and submits regulatory filings
Assists in hosting FDA and other regulatory audits
Stays abreast of proposed and mandated changes in regulations
Reviews proposed regulatory rules and assisting in drafting comments to regulatory agencies
Cooperates with other departments to ensure compliance with current regulations and preparation for changes in regulations
Guides archiving of all regulatory documents to ensure safe storage and accessibility
Provides guidance to junior level Regulatory Affairs colleagues
Ensures that Director of Regulatory Affairs is aware of any significant issues with regulatory affairs projects
Reviews product labels and marketing materials and provides input on related regulatory issues
Contributes to development of regulatory product strategies in collaboration with internal and external marketing, legal, and regulatory personnel
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 1/2 time may be necessary.
Bachelor's Degree in technical or regulatory field
Master's Degree in Regulatory Affairs and minimum of 3 years in an FDA-regulated industry, or minimum of 6 years experience including management of regulatory submissions
Understanding of regulatory frameworks, and the ability to interpret and apply new or emerging regulations
Ability to analyze complex regulations and ensure that company is in compliant with those regulations.
Fluent in English, strong verbal and written communication skills