Lead Regulatory Affairs Specialist

1 week ago

Toledo, Ohio, United States 24 Seven Talent Full time

Join a prominent beauty organization in Southern California as a Senior Manager of Regulatory Affairs, specializing in Personal Care and Cosmetics.

Position Overview

  • The Senior Manager of Regulatory Affairs will report directly to the Vice President of Quality Control and Regulatory Affairs, providing strategic leadership and oversight for all regulatory compliance initiatives at both domestic and international levels across various brands.
  • This role requires a comprehensive understanding of current and forthcoming regulations related to cosmetic ingredients, raw materials, packaging, labeling, claims, and other compliance areas.
  • Monitoring regulatory changes and legislative developments is essential to assess their impact on existing and forthcoming products.
  • The Senior Manager will collaborate closely with cross-functional teams to formulate regulatory strategies and ensure adherence to all relevant regulations.

Key Responsibilities

  • Collaborate with Marketing and Sales teams, along with other cross-functional leaders, to develop and implement a robust regulatory strategy for both domestic and international markets, ensuring compliance for all new product developments concerning chemical, formula, and packaging regulations for cosmetics and children's products.
  • Provide expert regulatory guidance, risk analysis, and insights for both current and future products to achieve compliance while meeting business objectives.
  • Ensure that all processes and procedures comply with applicable standards and regulations.
  • Proactively communicate within the organization regarding regulatory strategies, key issues, and other critical topics throughout the product lifecycle.
  • Work with the Marketing team to review and approve product labeling, artwork, and other promotional materials to ensure compliance with relevant regulations.
  • Maintain up-to-date knowledge of domestic and international regulations pertaining to cosmetics and children's products.
  • Oversee compliance initiatives driven by retailers, including Worldwide Environmental Regulatory Compliance Solutions (WERCS).
  • Manage compliance for existing finished goods and formulas, initiating changes as required by new regulations or business practices.
  • Direct staff to regularly audit regulatory files and control documents, such as Safety Data Sheets (SDS), Certificates of Analysis (COA), Specifications, and Stability data, ensuring accuracy and readiness for formal audits.
  • Assist with product recalls and support manufacturing centers and European Union compliance for REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals).
  • Ensure compliance with the Modernization of Cosmetics Regulation Act of 2022 (MOCRA).
  • Supervise the completion of necessary product filings for respective regions, including Health Canada CNF, EU CPNP, and California Safe Cosmetics Act.
  • Collaborate with consultants and internal personnel to register facilities and Over-the-Counter (OTC) products with the US-FDA and Health Canada, maintaining compliance as necessary.
  • Work with Marketing and regional distributors to register products in markets outside of the US, Canada, and the EU. Develop product testing protocols to meet the requirements of licensees and manage staff to execute these protocols.
  • Travel to facilities as required; international travel may also be necessary.

Qualifications

  • Education & Experience:
  • A minimum of a bachelor's degree in Chemistry or a related scientific discipline.
  • 10-12 years of experience in regulatory affairs within the cosmetic or personal care industry; experience in quality control is advantageous.
  • 5-7 years of supervisory or management experience, including team building and development.
  • Experience as an active participant in cosmetic-centric FDA audits is essential.
  • Strong understanding of regulations governing cosmetics, including US-FDA, Fair Packaging and Labeling Act (FPLA), Food, Drug, and Cosmetic Act (FDC), EU Cosmetic Regulation 1223/2009, and Health Canada regulations.

Skills & Abilities:

  • Willingness and ability to travel as needed.
  • Proven leadership skills in establishing work priorities for multiple projects, accepting responsibility, and adapting to changing priorities.
  • Demonstrated accuracy and thoroughness, with a focus on continuous improvement and quality enhancement.
  • Strong planning and analytical skills with a history of business impact in previous roles.
  • Proficiency in Microsoft Office Suite.

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