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Astrix Inc

Regulatory Affairs Consultant - Personal Care

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Job Description

Pay Rate Low:
150 |
Pay Rate High:
200 Job Description We are seeking a highly experienced Regulatory Affairs Consultant with a background in the cosmetics/personal care industry to provide short-term advisory support to a growing U.S.-based manufacturer. The consultant will provide expert guidance related to MoCRA compliance and cosmetic manufacturing requirements as the company prepares to transition into a new facility and build out a small-scale manufacturing suite. The consultant will also assess an interim production area and advise whether, and under what conditions, it may be used for limited-volume commercial manufacturing. This is a remote, project-based engagement requiring only a limited number of consulting hours . Key Responsibilities Assess the company's current operations and provide guidance regarding MoCRA compliance requirements and obligations. Identify applicable regulatory requirements associated with establishing and operating a small-scale cosmetics/personal care manufacturing facility. Advise on necessary regulatory documentation, procedures, records, and compliance controls. Provide guidance regarding cosmetic GMP requirements and industry best practices. Evaluate the proposed temporary manufacturing setup and advise on its suitability for producing small commercial batches. Identify compliance gaps, potential risks, and recommended actions that should be addressed before manufacturing begins. Provide a practical, prioritized roadmap for achieving and maintaining regulatory compliance. Candidate Qualifications 10+ years of Regulatory Affairs or Regulatory Compliance experience, preferably at a senior/consultant level.
Required:
Direct professional experience within the cosmetics, beauty, skincare, or personal care industry. Strong working knowledge of MoCRA and
U.S. FDA
cosmetic regulatory requirements. Hands-on experience supporting or advising cosmetic/personal care manufacturing operations. Knowledge of cosmetic GMPs, facility requirements, SOPs, documentation, recordkeeping, and quality systems. Experience with areas such as facility registration, product listing, safety substantiation, labeling, and adverse-event requirements. Experience assessing manufacturing environments and providing practical recommendations for small-scale or limited-batch production. Ability to quickly assess an organization's current state and translate regulatory requirements into clear, actionable recommendations. Available for a short-duration consulting engagement of several hours , with the potential for additional advisory support as needed.