Global Regulatory Compliance Specialist

Job Description

Job Description

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.

Core Duties and 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

Position 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