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- Tasks: Lead compliance efforts and manage regulatory submissions for cosmetics in the U.S. and EU.
- Company: Coronado Research is a forward-thinking company focused on innovative beauty and personal care products.
- Benefits: Enjoy flexible hours, remote work, and the chance to shape regulatory strategies.
- Why this job: Join a dynamic team and make an impact in the evolving cosmetics industry.
- Qualifications: 10+ years in regulatory affairs with expertise in FDA and EU regulations required.
- Other info: This is a freelance role, perfect for independent professionals seeking part-time opportunities.
The predicted salary is between 48000 - 72000 £ per year.
Freelance Director of Regulatory Affairs – Cosmetics (U.S. & EU)
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Freelance Director of Regulatory Affairs – Cosmetics (U.S. & EU)
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Freelance Director of Regulatory Affairs – Cosmetics (U.S. & EU)
Location: Remote
Contract Type: Freelance / Consultant
Reports To: EVP Regulatory Affairs
Position Overview:
We are seeking an experienced and strategic Regulatory Affairs Director with expertise in cosmetic product regulations across the United States and European Union. This freelance role is ideal for a professional who can lead compliance efforts, manage regulatory submissions, and guide product development in line with evolving global legislation.
Key Responsibilities:
Regulatory Strategy & Compliance
– Develop and implement regulatory strategies aligned with:
– U.S. regulations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Modernization of Cosmetics Regulation Act (MoCRA).
– EU regulations, including Regulation (EC) No 1223/2009 and its amendments such as Regulation (EU) 2025/877.
– Ensure product safety, labeling, and marketing materials comply with:
– FDA requirements for facility registration, product listing, adverse event reporting, and safety substantiation.
– EU mandates on ingredient bans, nanomaterial restrictions, and CMR substance prohibitions.
Product Development Support
– Advise on regulatory implications of formulations and claims.
– Review technical documentation, ingredient safety data, and labeling for compliance.
Submission & Communication
– Manage:
– FDA Voluntary Cosmetic Registration Program (VCRP) and Cosmetic Product Ingredient Statements (CPIS).
– Liaise with FDA, EFSA, European Commission, and national competent authorities.
– Conduct regulatory risk assessments and develop mitigation strategies.
– Maintain comprehensive regulatory documentation and ensure audit readiness.
Qualifications:
– 10+ years\’ experience in regulatory affairs, with a focus on cosmetic products.
– Proven success navigating FDA, MoCRA, and EU Regulation 1223/2009 compliance.
– Strong understanding of:
– Good Manufacturing Practices (GMP) and labeling laws in both regions.
– EU Annex II (prohibited substances), Annex III (restricted substances), and Annex V (preservatives).
– Excellent communication, analytical, and project management skills.
– Ability to work independently and manage multiple international projects.
Preferred Skills:
– Advanced degree in Science, or related field.
– Experience with digital regulatory platforms and dossier preparation tools.
– Familiarity with nanomaterial, fragrance allergen, and CMR substance regulations.
– Flexible hours and remote work.
– Opportunity to shape regulatory strategy for innovative beauty and personal care products.
Seniority level
-
Seniority level
Director
Employment type
-
Employment type
Part-time
Job function
-
Job function
Consulting
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Freelance Director of Regulatory Affairs - Cosmetics (U.S. & EU) employer: Coronado Research
Contact Detail:
Coronado Research Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Freelance Director of Regulatory Affairs - Cosmetics (U.S. & EU)
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with cosmetics. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and regulations.
✨Tip Number 2
Familiarise yourself with the specific regulations mentioned in the job description, such as the FD&C Act and EU Regulation 1223/2009. Being able to discuss these regulations confidently during interviews will demonstrate your expertise and commitment to the role.
✨Tip Number 3
Consider reaching out to current or former employees of Coronado Research on professional networking sites. They can provide insights into the company culture and expectations, which can help you tailor your approach when applying.
✨Tip Number 4
Stay updated on recent changes in cosmetic regulations both in the U.S. and EU. This knowledge will not only prepare you for potential interview questions but also show that you are proactive and engaged in your field.
We think you need these skills to ace Freelance Director of Regulatory Affairs - Cosmetics (U.S. & EU)
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Freelance Director of Regulatory Affairs position. Familiarise yourself with U.S. and EU cosmetic regulations to tailor your application effectively.
Tailor Your CV: Highlight your relevant experience in regulatory affairs, particularly in cosmetics. Emphasise your knowledge of FDA and EU regulations, as well as any specific achievements that demonstrate your expertise in compliance and product safety.
Craft a Compelling Cover Letter: Write a cover letter that showcases your strategic approach to regulatory affairs. Discuss how your background aligns with the company's needs and express your enthusiasm for contributing to innovative beauty and personal care products.
Proofread and Edit: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your application is clear, concise, and professional, reflecting your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Coronado Research
✨Know Your Regulations
Make sure you have a solid understanding of both U.S. and EU cosmetic regulations, including the FD&C Act, MoCRA, and Regulation (EC) No 1223/2009. Be prepared to discuss how these regulations impact product safety and compliance.
✨Showcase Your Experience
Highlight your 10+ years of experience in regulatory affairs, particularly with cosmetic products. Use specific examples from your past roles to demonstrate your success in navigating complex regulatory environments.
✨Prepare for Technical Questions
Expect questions about Good Manufacturing Practices (GMP), labeling laws, and specific regulations like EU Annex II and III. Brush up on these topics so you can confidently answer any technical queries during the interview.
✨Emphasise Communication Skills
As this role involves liaising with various regulatory bodies, be ready to discuss your communication strategies. Share examples of how you've effectively managed stakeholder relationships and communicated complex regulatory information.
