Regulatory Affairs Associate II

Position Title: Regulatory Affairs Associate II

Reports to: Regulatory Affairs Manager

Company Location: Irving, TX

Location of Position: Hybrid

Company Background

Revision Skincare, located in Irving, TX, provides dermatologists, plastic surgeons and medical spas with clinically-proven, high-performing skincare products. Using only premium quality ingredients, the Revision Skincare collection was formulated to provide targeted solutions for enhancing skin’s appearance and reducing signs of aging.

Scope of Position

Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Associate is responsible for supporting Revision’s marketing and global expansion efforts. Tasks include assisting the Regulatory Affairs Manager in satisfying all document and testing requirements to register Revision products in foreign countries. An additional area of focus is collaborating with the Marketing and R&D Departments to support the product claims review process to ensure compliance to regulations. Objectives also include helping with foreign compliance audits and regulatory inquiries. 

Job Description

• Gather prepare and/or lead the compilation of necessary documents for product registrations and/or notifications with relevant authorities domestically and internationally
• Maintain and manage global regulatory files and databases to ensure information remains accurate, current, and compliant.
• Support the review and approval of professional and consumer-facing communication (LCR process) for compliance with applicable US and international regulations.
• Facilitate and support international labelling, including coordination with internal stakeholders and alignment with market-specific regulatory requirements. 
• Facilitate the creation of Cosmetic Ingredient Declarations (CID) and OTC Drug Fact(s) label content.

• Monitor, interpret, and assess global regulatory requirements, guidance, and industry trends, and communicate regulatory risks, changes and/or impacts to management and cross-functional teams. 

• Review technical and regulatory documentation from external partners (e.g.; testing and stability reports) and identify or escalate potential gaps or inconsistencies. 
• Support relationships with third party international regulatory agencies and partners to facilitate product notification/registrations and ongoing compliance.

• Collaborate and communicate cross-functionally with Marketing, Sales, Quality, R&D, and Operations Departments to support compliant product development, launch, and lifecycle management.
• Maintain and expand regulatory knowledge concerning domestic and international regulations, with scope and depth commensurate with role level and responsibilities.
• Serve as a central regulatory partner across multiple teams to support compliant product transitions and proactively manage activities that reduce compliance risk and business disruption.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their manager.

Requirements

• Must be a US Citizen or eligible to work in the US
• A bachelor's degree in science, engineering or a related field
• A minimum of 2-5 years of domestic and international regulatory experience, or equivalent experience
• Knowledge and experience with OTC and cosmetic topical formulations
• Excellent organizational skills
• Detail oriented with good analytical and problem-solving capabilities
• Ability to work collaboratively in a team environment
• Strong communication and interpersonal skills