Global Regulatory Compliance Specialist

Life Extension Foundation Buyers Club Inc•Fort Lauderdale, FL

1d•Onsite

About The Position

This position provides expertise and is responsible for managing all documentation and regulatory reviews for expansion of Life Extension products globally. Collaborates with different functional areas (Purchasing, Product Development) and external consultants to provide regulatory compliance feedback during various steps of the product launch process as well as review of existing product reformulation for global expansion.

Requirements

Bachelor’s degree (or equivalent) in science or health-related field
2+ years of dietary supplement experience or equivalent within a Quality or Regulatory Affairs environment; demonstrated knowledge of international regulations strongly preferred
Baseline understanding of US regulations and labelling requirements
Ability to interact with associates on all levels and communicate effectively across several functional areas
Strong organization skills and detail oriented
Excellent communication skills; verbal and written, including technical writing
Ability to translate highly technical information so it is understandable for the target audience

Responsibilities

Create and maintain product dossiers as required to support international business
Oversee, prepare, and manage various submissions and responses to regulatory authority questions ensuring adherence to national and international regulations and standards (i.e., FDA, Health Canada, European Union)
Assist with regulatory review of current product formulations to ensure compliance with international requirements for current active projects
Work with suppliers to ensure documentation and product requirements are met for international market entry
Communicate effectively across several different functional areas including internal cross-functional teams (purchasing, product development, marketing) and external vendors (consultants, contract manufacturers, raw material suppliers)
Serve as a liaison with external consulting firms engaged in activities related to international compliance, labelling, or product registration
Provide global regulatory oversight and compliance feedback for new item concepts and reformulation of existing items
Review proposed labelling to ensure intended use and claims are supported and domestic and international regulations are met
Organize and manage status of all in-process regulatory projects
Organize and track product registrations when approval from governing authorities has been received
Help develop and maintain a regulatory database
Assist with US Regulatory inquires when needed
2 onsite days per week is an essential function of this position
Additional duties as needed