Regulatory Specialist

Mackie Myers; Los Angeles (CA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid time off and company holidays

Professional development opportunities

Job summary

Mackie Myers is seeking a detail-oriented Regulatory Specialist to join our R&D team in Los Angeles. You will help ensure our cosmetic and OTC products comply with federal, state, local, and international regulations, including MoCRA and ISO 22716 GMP.

You will collaborate with R&D, Quality Assurance, and Operations to maintain product safety, quality, and regulatory readiness across manufacturing, and will train staff on regulatory practices and documentation.

Qualifications

• Bachelor's degree or equivalent in a related science field with regulatory focus.
• 3–5 years of proven experience as a Regulatory Specialist in cosmetic contract manufacturing or FDA-regulated industry.
• Strong knowledge of global cosmetic regulations including FDA, MoCRA, and ISO 22716 GMP.
• Familiarity with ingredient safety assessment, risk assessment, labeling, and product registration/notification processes.

Responsibilities

• Provide regulatory guidance on formulation and label changes with R&D and design teams.
• Maintain compliance with FDA cosmetics and OTC drug regs, MoCRA, and ISO 22716 GMP.
• Research evolving regulations and translate findings into updated policies and procedures.
• Prepare and maintain regulatory documentation: PIFs, SDS, OTC labeling, and facility registrations.
• Review labeling and packaging for regulatory accuracy and manage labeling compliance.

Skills

Regulatory knowledge

Analytical problem-solving

Cross-functional collaboration

Detail-oriented

Project management

Communication skills

Education

Bachelor's degree in Chemistry, Pharmacy, Regulatory Affairs, Biochemistry, Business, or related field

Associate's degree with equivalent experience

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Regulatory databases

Job description

Our company is an established contract manufacturer of cosmetic and OTC (over-the-counter) personal care products based in Los Angeles, producing formulations on behalf of a range of brand clients. We are looking for a detail-oriented Regulatory Specialist to join our R&D team and help ensure our products and facility meet all applicable federal, state, local, and international regulatory requirements.

Position Summary

The Regulatory Specialist assists in obtaining and maintaining government approval for OTC drug, cosmetic, and related products, helping the company meet all international, federal, state, local, and industry regulations that apply. This role interprets and researches regulations and standards, develops compliance policies and procedures, trains employees on regulatory matters, and supports the company's continued compliance with MoCRA (2022) and ISO 22716:2007 Cosmetic GMP. The Regulatory Specialist also represents the company's interests with regulatory authorities and industry associations, and works closely with R&D, Quality Assurance, and Operations to ensure product safety, quality, and consistency.

Key Responsibilities

• Provide regulatory guidance on all proposed changes to product formulation and label design, partnering closely with R&D and label design teams to ensure regulatory controls are followed.
• Support and maintain compliance with FDA cosmetic and OTC drug regulations, including MoCRA (Modernization of Cosmetics Regulation Act) requirements and ISO 22716:2007 Cosmetic Good Manufacturing Practice (GMP) standards.
• Interpret and research evolving global, federal, state, and local regulations, and translate findings into updated compliance policies, procedures, and practices.
• Prepare, review, and maintain regulatory documentation, including Product Information Files (PIFs), Safety Data Sheets (SDS), OTC drug labeling requirements, and facility registrations.
• Review product labels, packaging copy, and marketing claims for regulatory accuracy, and manage the end-to-end labeling compliance process.
• Conduct ingredient safety and risk assessments to support new and existing product formulations.
• Build and maintain strong working relationships with regulatory authorities, and represent the company's interests by providing feedback on proposed regulations to agencies and industry associations.
• Collaborate with Quality Assurance and Operations teams to ensure product safety, quality, and consistency, and that regulatory requirements are met across manufacturing.
• Serve as a regulatory point of contact for customer issues and concerns, and implement corrective actions to prevent recurring occurrences.
• Deliver training to employees on regulatory practices, labeling requirements, and compliance procedures.
• Identify and implement improvements to regulatory systems, recordkeeping, and documentation processes; ensure regulatory and compliance records are properly maintained.
• Monitor and stay current on regulatory changes and developments in the regulatory environment.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Regulatory Affairs, Biochemistry, Business, or a related science field (or an Associate's degree in a related science with equivalent experience).
• 3-5 years of proven experience as a Regulatory Specialist in a cosmetic contract manufacturing environment and/or FDA-regulated industry.
• Strong knowledge of global cosmetic regulations and guidelines, including FDA, MoCRA, and ISO 22716 GMP requirements.
• Familiarity with ingredient safety assessment, risk assessment methodologies, and regulatory requirements for labeling, claims, and product registration/notification.
• Strong understanding of Quality Management Systems (QMS) and Good Manufacturing Practices (GMP) applicable to cosmetics and OTC products.
• Excellent analytical and problem-solving skills to interpret complex regulations and develop practical compliance strategies.
• Effective communication and collaboration skills to work cross-functionally and interact directly with regulatory authorities and clients.
• Detail-oriented and well organized, with strong project management skills and the ability to manage multiple projects simultaneously.
• Self-motivated, able to work independently, and committed to a high standard of integrity.

Preferred Qualifications

• Bilingual written communication skills (English/Spanish), particularly for detailed technical material.
• Experience communicating with cross-functional teams and customers, including verbal presentations.
• Full proficiency in the Microsoft Office suite (Excel, Word, Outlook, PowerPoint).
• Experience with international cosmetic regulations (EU, Health Canada, or other global markets).
• Prior experience supporting OTC drug product registrations in addition to cosmetics.

This role is based primarily in an office/administrative setting with regular interaction with R&D and manufacturing teams. Some exposure to an industrial production environment should be expected, including walking, standing, bending, and occasional lifting of materials up to 50 pounds. Compliance with company PPE policy (safety glasses, appropriate attire, safety shoes, etc.) is required when on the production floor, which may involve exposure to hot and cold temperatures, noise, limited dust, and chemicals. Some overtime may be necessary to meet deadlines or respond to urgent compliance matters.

• Base salary range: $70,000-$90,000, commensurate with experience.
• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off and company holidays.
• Opportunities for professional development and growth within a growing manufacturing organization.

Additional Notes

• Candidates must be legally authorized to work in the United States on a full-time basis and not require, now or in the future, employer sponsorship for a work visa.