Regulatory Affairs Specialist

Job Description

Job Description

Essential Duties and Responsibilities:

• Performs regulatory assessments of formulations and labeling for various regions, including but not limited to Canada, EU, ASEAN, Japan and for various product types, including cosmetics and OTC drugs.
• Reviews chemical ingredients and recommends the warning labels for each product.
• Assists in monitoring regulations and standards for changes and assesses the impact.
• Coordinates and compiles Regulatory documents that are intended to be submitted to the FDA and other Regulatory Agencies as required, including international registration documents for cosmetic and drug products.
• Evaluates proposed product formula modifications for global regulatory impact.
• Liaises with international distributors and partners, plus internal departments, to request, coordinate, and provide regulatory information.
• Maintains documentation and related systems necessary for efficient operation of the department.
• Provides support to other regulatory team members.

Knowledge, Skills & Abilities:

• Bachelor’s degree in a scientific discipline and/or a combination of school and experience.
• 3-5 years of related work experience in the cosmetic industry preferred.
• Strong knowledge of the cosmetic industry, including OTC drug categories as well as manufacturing practices.
• Working knowledge of global cosmetic and drug regulations, including the Food, Drug, and Cosmetic Act, Fair Packaging and Labeling Act, 21 CFR 211 Good Manufacturing Practices, as well as EU, Canada, and Asian international cosmetic regulations.
• Strong interpersonal, communication, and organizational skills.
• Ability to convey information in a clear, focused, and concise manner.
• Proactive and self-motivated with a collaborative attitude and a desire to continuously learn.

Work Environment: The work environment is indoors in a professional office environment. The floor surfaces are carpeted in office areas and conference rooms with vinyl floor covering typical in hallways, break rooms, and computer rooms. Occasionally, they may work in a warehouse environment, as part of a project, and/or in the field with outside sales.

Work Hours: The work schedule is 5 days per week, 8 hours per day. Initial start time may vary, with work hours typically from 8 am-5 pm. Work hours and shifts are subject to change depending on operating business conditions and needs. The position resides in Orange County but is hybrid, with 2 days being remote work.