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Regulatory Compliance Manager

2 months ago

Irving, Texas, United States Revision LLC Full time
Job Overview

As a pivotal member of Revision LLC, the Regulatory Affairs Manager plays a crucial role in aligning with the Director's objectives to develop both immediate strategies and sustainable solutions. This position entails overseeing a team of regulatory professionals dedicated to advancing our product innovation and ensuring compliance across our existing portfolio.

Key Responsibilities

  • Lead a team of regulatory professionals, ensuring effective training and delegation of projects to maintain regulatory compliance.
  • Work collaboratively with various departments to offer regulatory and technical insights for both domestic and international product launches.
  • Perform regulatory evaluations on new ingredients, formulations, and modifications to existing products.
  • Assess and authorize product claims, labeling, marketing materials, and other documentation to guarantee adherence to regulatory standards.
  • Manage domestic and international regulatory submissions, including product registrations and post-market surveillance documentation.
  • Conduct risk evaluations and formulate strategies to mitigate regulatory challenges.
  • Establish a framework and standard operating procedures (SOPs) for compliance management throughout the organization.
  • Respond to regulatory intelligence and competitive research inquiries to support product development initiatives.
  • Stay informed on regulatory changes and communicate their impact to relevant stakeholders.
  • Compile and maintain Product Information Files (PIF) along with all necessary testing reports, ingredient documentation, specification sheets, safety data sheets, and certifications.

Essential Skills

  • In-depth knowledge of personal care, cosmetic, and OTC regulations at state, federal, and international levels.
  • Meticulous attention to detail with the ability to accurately interpret technical documents, scientific data, and regulatory guidelines.
  • Exceptional written and verbal communication skills, capable of conveying complex regulatory information to diverse audiences.
  • Strong project management capabilities with the ability to juggle multiple projects effectively.
  • Proficient in utilizing regulatory databases and software for tracking submissions and documentation.
  • Robust analytical and problem-solving skills to identify and address regulatory issues efficiently.
  • Proven ability to collaborate within cross-functional teams and influence stakeholders across various levels.

Qualifications

  • Bachelor's degree in a scientific discipline, engineering, or a related field; a Master's degree is preferred.
  • 5-7 years of experience in global regulatory affairs within the personal care, cosmetic, and OTC sectors, with a focus on international compliance.
  • 2-5 years of management experience is preferred.
  • Demonstrated knowledge of MoCRA, FDA, EU regulations, Canada, and 21 CFR Part 330.

Leadership Attributes

  • Proactively drives changes related to marketed products.
  • Collaborates effectively across organizational boundaries.
  • Inspires and cultivates trusted relationships with team members and stakeholders.