Regulatory Affairs Associate I

Position Title:  Regulatory Affairs Associate I

Reports to:  Senior Regulatory Affairs Manager

Company Location:  Irving, TX

 

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

The Regulatory Affairs Associate I is an entry-level role with opportunity to learn and grow with the goal to provide regulatory support to US FDA, Health Canada, EU, Asia and other International Regulatory Licensing and Registration Agencies. This position reports to the Senior Regulatory Affairs Manager.

Job Description

  • Help to gather and/or prepare necessary documents for product registrations and/or notifications with relevant authorities domestically and internationally.
  • Maintain global regulatory files and databases to ensure accurate and up-to-date information.
  • Participate in regulatory monitoring and impact analysis for Global business requirements.
  • Facilitate the label/marketing material review process to ensure timely review of necessary documents.
  • Participates in the review and approval of professional and consumer facing communication (LCR Process) for compliance with applicable US regulations.
  • Collaborate and communicate cross-functionally with Marketing, Sales, Quality, R&D, and Operations Departments to maintain a positive and optimal environment.
  • Continue acquiring knowledge concerning domestic and international regulations.

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 U.S. Citizen or eligible to work in the U.S.
  • Bachelor’s degree with 0-3 years of experience in life sciences industry
  • Detail oriented with problem solving ability
  • Excellent verbal and written communication skills
  • Ability to work collaboratively in a team environment

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