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.

People are our business worldwide

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.