At a Glance
- 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.
- Other info: This is a freelance role, perfect for independent professionals seeking part-time opportunities.
- 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.
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
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Seniority level
Director
Employment type
-
Employment type
Part-time
Job function
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Job function
Consulting
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Freelance Director of Regulatory Affairs - Cosmetics (U.S. & EU) in Portsmouth employer: Coronado Research
Coronado Research is an exceptional employer for professionals seeking meaningful freelance opportunities in the regulatory affairs sector, particularly within the cosmetics industry. With a flexible remote work environment, employees can enjoy a healthy work-life balance while contributing to innovative beauty and personal care products. The company fosters a culture of growth and collaboration, providing ample opportunities for professional development and the chance to shape regulatory strategies that impact global markets.
StudySmarter Expert Advice🤫
We think this is how you could land Freelance Director of Regulatory Affairs - Cosmetics (U.S. & EU) in Portsmouth
✨Get Your Portfolio Ready
When it comes to compliance and risk, a solid portfolio is crucial. Showcase your past work, particularly any interesting case studies or projects that relate to regulations or risk management. This not only demonstrates your expertise but also helps you stand out to potential clients.
✨Join Compliance Networks
In the compliance-risk world, connecting with industry professionals can be a game-changer. Join associations like the Association of Certified Compliance Professionals or attend events focused on regulatory changes. These are great places to meet potential clients and learn about freelance opportunities.
✨Utilise Online Freelance Platforms
Platforms like Upwork or Freelancer can be goldmines for freelance compliance work. Keep an eye out for jobs that require specific compliance skills, and don’t hesitate to pitch your expertise. Make your profile shine with relevant certifications and experiences.
✨Tap Into Our Community
Check out our opportunities on the StudySmarter site! We often post freelance roles that could be right up your alley. Don’t miss out on applying directly through us, as we want to support you in landing your dream freelance compliance gig!
We think you need these skills to ace Freelance Director of Regulatory Affairs - Cosmetics (U.S. & EU) in Portsmouth
Some tips for your application 🫡
Show Off Your Compliance Expertise:In the compliance-risk field, it's crucial to highlight your knowledge of regulations and risk management frameworks. Make sure your CV showcases relevant certifications like CISA or CISM, and any experience with compliance audits. This will demonstrate your capability to navigate the complexities of compliance effectively.
Build a Strong Portfolio:As a freelancer, your portfolio is your best friend! Include case studies of past compliance projects, detailing the challenges faced and the solutions you implemented. Potential clients at Coronado Research will love seeing the tangible impact of your work and your analytical skills in action.
Tailor Your Application:When applying to Coronado Research, deep dive into their specific compliance needs. Research their industry and mention how your unique skill set can address their challenges. A personalised touch can go a long way in freelance applications, showing you’re not just sending out a generic CV.
Discuss Your Availability and Rates:In your application, it's essential to be upfront about your availability and rates. Freelance work often involves negotiating terms, so outlining what you can offer and your expected compensation will save time and set clear expectations from the start.
How to prepare for a job interview at Coronado Research
✨Showcase Your Compliance Knowledge
In the freelance compliance-risk world, it's crucial to highlight your understanding of regulations and frameworks relevant to the industry. During your chat with Coronado Research, be ready to discuss specific laws that impact their operations and show how your previous projects tackle compliance challenges.
✨Prepare Your Portfolio of Solutions
As a freelancer, your portfolio is your golden ticket! Have examples ready that demonstrate your ability to identify and mitigate risks, complete with case studies from past gigs. This will help you illustrate your hands-on experience and problem-solving skills effectively to Coronado Research.
✨Be Ready for Scenario Questions
Expect the interviewers at Coronado Research to throw some scenario-based questions your way. They might ask how you'd approach a particular risk situation or compliance issue. Think through some real-life examples or hypothetical situations beforehand to display your analytical skills and risk-assessment strategies.
✨Discuss Your Flexibility and Approach to Projects
As a freelancer, it’s key to convey how you adapt to different clients and workflows. Talk to Coronado Research about your past experiences working independently and how you structure your projects, demonstrating your professionalism and ability to meet deadlines without micromanagement.
