Regulatory Affairs Manager

2 months ago

Glendale Heights, United States Universal Beauty Products Inc. Full time

Universal Beauty Products, Inc. has been dedicated to making the world's finest, high quality products in the beauty and personal care industry. Our customers, both large and small, are based in countries all over the world, and as a company, we pride ourselves on our commitment to producing innovative and performance driven products. We are under new management and growing, so now is a great time to join our team. Please note this is a on-site position.


In addition to competitive pay and benefits, we provide a safe and inclusive work environment that appreciates diversity, promotes development and allows our associates to be their authentic selves.


The Regulatory Affairs Manager serves as a technical resource to meet domestic and global regulatory compliance demands within the cosmetic industry. This role will provide regulatory support for new product introduction and changes to existing products.


Responsibilities

  • Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on personal care products.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents; disseminate information as appropriate.
  • Identify, obtain and maintain relevant guidance documents, international standards, or consensus standards and complete gap analysis on new or updated regulations and standards to ascertain regulatory impact and recommend changes to ensure compliance. (i.e., SDS, INCI Declarations, COA, COFS, COO)
  • Be Subject Matter expert on MoCRA and authorized representative for the company.
  • Create framework and SOP for managing regulatory affairs across all facets of the business.
  • As the regulatory expert, you are responsible for leading the preparation, documentation and submission of regulatory applications for UBP products
  • Support Quality Management System compliance including writing and revising relevant SOPs, training functional groups, design document review, change management, and constructively implementing compliance mechanisms for new regulations and regulatory guidance
  • Provide technical interface with FDA and respond to questions; establish and maintain good relationships with agency personnel.
  • Represent the Regulatory Affairs department in project development meetings and assist in developing regulatory strategies
  • Provides regulatory guidance and training to team members, both internally and externally
  • Coordinate, support, and author clear and concise regulatory filings and responses for both domestic and international establishment / product registrations.
  • Actively participate in evaluating the regulatory compliance of document / product / process / test method changes.
  • Participate in Risk Management activities such as: review and approval of risk documentation outputs, involvement in risk management review meetings; contextualizing compliance requirements for effective risk management; directing risk mitigation activity
  • Organize and maintain hard copy and electronic department files.


Qualifications/Skills:

  • Bachelor’s degree with concentration in Chemistry, Biology, Chemical Engineering or related field with 5 years of regulatory experience in cosmetic, consumer product, pharmaceutical or related filed
  • Understanding of product life cycle process, design control and/or risk management.
  • Demonstrated ability representing regulatory compliance in cross-functional team setting and project management experience
  • Working knowledge of laws, regulation, and relevant compliance programs under FDA, Health Canada, EPA, OSHA, CARB and EU Compliant
  • Ability to work and learn in a fast-paced environment with shifting changes in prioritization based on regulatory and business needs..
  • Strong interpersonal, oral, and written communication skills.

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