Regulatory Affairs Associate I - Skincare Labeling and Global Cosmetic OTC Compliance

Regulatory Affairs Associate I - Skincare Labeling and Global Cosmetic OTC Compliance
Location: Hybrid - Irvine, California
Length of Assignment: 1 year with potential extension
Pay Rate: $33-36/hr (medical insurance benefits available at a cost)

Job Description:
The Regulatory Affairs Associate I supports the development and implementation of global regulatory strategy for skincare products. Under supervision, this role reviews, plans, and prepares regulatory documents and labeling for cosmetic and over-the-counter product registrations and updates. The associate also researches and interprets health-authority regulations and guidance and communicates relevant regulatory information to cross-functional teams.

• Review product labeling for accuracy and applicable legal and regulatory requirements, and communicate planned or approved changes to operations, medical affairs, commercial, and other cross-functional teams.
• Provide regulatory guidance to internal departments to support compliance with applicable requirements.
• Conduct regulatory assessments of product changes, labeling revisions, and new-product introductions.
• Review international regulations to assess and support market-expansion feasibility.
• Monitor and track federal, state, and international regulatory developments relevant to business operations and assess their impact on skincare products.
• Generate ingredient lists and cosmetic or OTC formulation assessments.
• Review and approve formulations and labeling for local and global compliance.
• Prepare origin, animal-testing, allergen, CMR/nano, gluten-free, BSE, and other requested statements following review of formulas and ingredients.
• Obtain required regulatory documentation from raw-material suppliers and provide regulatory insight to formulators developing globally and locally compliant formulations.
• Prepare and submit regulatory documents for cosmetic registrations and respond to regulatory questions as needed.
• Archive submissions, internal memoranda, key correspondence, and other regulatory activities, and provide status updates to management.

Required Qualifications:

• Ability to critically and effectively review detailed information supporting labeling revisions, including all applicable regulations.
• Working knowledge of OTC drug monographs and cosmetic-product requirements.
• Basic knowledge of personal-care product regulatory affairs across development, commercialization, and operations.
• Ability to manage multiple priorities and projects while meeting strict deadlines.
• Strong attention to detail with demonstrated proofreading skills and the ability to check documents for accuracy and consistency.
• Excellent written and verbal communication skills.
• Strong interpersonal skills and the ability to positively and effectively influence others.
• Ability to understand and apply business drivers outside Regulatory Affairs.

Education and Experience:

• Bachelor's degree in a scientific field plus two years of Regulatory Affairs experience, or equivalent relevant work experience.
• Master's degree in a scientific field plus one year of Regulatory Affairs experience, or equivalent relevant work experience.
• Doctoral degree in a scientific field; prior Regulatory Affairs experience is not required.

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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.