Regulatory Affairs Coordinator

POSITION SUMMARY:

This role is integral to our mission of delivering compliant and market-ready cosmetic and OTC products. The ideal candidate will possess deep expertise in regulatory requirements, a keen eye for detail, and the ability to navigate complex regulatory landscapes both domestically and internationally. You will play a critical role in ensuring that our manufacturing processes and products adhere to all relevant regulations, facilitating seamless product launches, and supporting our clients' regulatory strategies.

JOB DUTIES AND RESPONSIBILITIES:

• Maintain and organize regulatory documentation including but not limited to ILs, QQs, SDS, raw material documentation, and regulatory statements.
• Assist in reviewing formulas for compliance with FDA regulations, MoCRA requirements, EU Cosmetic Regulation, and other international standards as applicable.
• Support the review of product labels, packaging, and marketing collateral to ensure compliance with regulatory and customer requirements.
• Generate regulatory statements such as Origin, Animal Testing, Allergen, CMR/Nano, BSE, and other client-specific documentation.
• Track and maintain raw material documentation including specifications, COAs, and regulatory data to ensure completeness and accuracy.
• Assist in monitoring regulatory changes and communicate relevant updates to the Regulatory team.
• Support preparation of regulatory submissions and product registrations under supervision (e.g., MoCRA listings, international notifications).
• Assist in conducting basic regulatory assessments and escalate potential compliance risks to senior team members
• Maintain organized records within regulatory systems (e.g., Coptis or equivalent databases)\
• Support continuous improvement of regulatory processes, templates, and tracking tools
• All duties assigned to move department forward.

QUALIFICATIONS:

• Bachelor’s degree in Chemistry, Biology, Public Health, or related scientific field
• 0–3 years of experience in regulatory affairs, cosmetics, or personal care industry
• Comprehensive understanding of FDA regulations, EU Cosmetics Regulation, and other key international regulatory frameworks relevant to cosmetic and OTC products.
• Basic understanding of FDA cosmetic regulations and labeling requirements; exposure to international regulations is a plus

REQUIRED SKILLS:

• Strong attention to detail with the ability to review and manage regulatory data accurately
• Effective written and verbal communication skills
• Ability to interpret regulatory requirements with guidance and apply them to product scenarios
• Strong organizational skills with the ability to manage multiple projects and deadlines
• Proficiency in Microsoft Office (Excel, Word, Outlook)
• Experience with Coptis, NetSuite, or similar systems is a plus

PHYSICAL DEMANDS AND WORKING ENVIRONMENT ACKNOWLEGEMENT:

• Ability to lift at least 50lbs
• Ability to sit for full work shift