Regulatory Affairs Specialist

job
  • Universal Beauty Products Inc.
Job Summary
Location
Glendale Heights ,IL
Job Type
Contract
Visa
Any Valid Visa
Salary
PayRate
Qualification
BCA
Experience
2Years - 10Years
Posted
03 Feb 2025
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Job Description

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 Specialist 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. This role will work with Quality staff, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies and will report directly to the Director of Regulatory Affairs.

This position is not eligible for sponsorship or relocation.


Responsibilities

  • Serve as a site subject matter expert for planning, coordinating, and implementing regulatory strategies for products requiring domestic and/or international governmental approval.
  • 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)
  • 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.
  • 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.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Qualifications/Skills:

  • Bachelor’s degree with concentration in Chemistry, Biology, Chemical Engineering or related field with 3 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.
  • Ability to work effectively with teams with limited supervision.
  • Strong interpersonal, oral, and written communication skills.


Universal Beauty Products, Inc. successfully serves the health and personal care products markets. For over a decade, the company has been dedicated to making and bringing to the marketplace the world's finest, high quality products. Our customers, both large and small, are national as well as internationally based. More than 100, 000 square foot facility houses Universal Beauty Products research and development laboratories, sales and marketing staff, manufacturing, customer services, administration and warehouse operations. All of the company's employees are committed to producing performance proven products and services.

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