Regulatory Affairs and Quality Assurance Manager
Job Description
About The Company
This established and fast-growing skincare brand is renowned for delivering premium, science-backed products. With a strong commitment to global expansion, they are seeking a talented individual to lead compliance initiatives, oversee FDA and international regulations, and ensure their premium reputation in the skincare industry remains unparalleled.
The Role
What You’ll Do
Regulatory Compliance & FDA Oversight
- Ensure all products meet international skincare regulations by managing product registrations and maintaining compliance documentation.
- Lead the charge on FDA oversight, ensuring products align with OTC and cosmetic standards.
Product Testing & Claims Validation
- Oversee clinical and stability testing to validate product claims and determine the need for long-term studies.
- Guarantee that all product claims are scientifically substantiated.
International Compliance & Market Entry
- Manage global regulatory requirements, including ingredient restrictions, packaging guidelines, and product classification, to facilitate smooth international expansion.
- Stay ahead of the curve with market-specific regulations to streamline entry into new regions.
CMO & R&D Coordination
- Collaborate with contract manufacturers (CMOs) and R&D teams to ensure formulations align with regulatory standards.
- Drive production feasibility, supplier negotiations, and ensure seamless alignment between innovation and compliance.
Ingredient Reformulation & Compliance
- Evaluate regulatory implications for reformulated products, ensuring ongoing compliance with OTC regulations and market standards.
Product Ownership & IP Management
- Maintain meticulous records of formulations, testing protocols, and product registrations to secure seamless manufacturer transitions and safeguard intellectual property.
Adverse Reaction & Quality Complaints Management
- Manage and track adverse reactions reported by users, ensuring timely reporting and appropriate regulatory responses.
- Oversee the resolution of quality complaints and implement improvements to prevent future issues.
Batch Record Management
- Handle batch record reviews to ensure manufacturing processes meet regulatory and quality standards.
- Maintain accurate and thorough records to ensure compliance and facilitate smooth audits.
Education & Sales Support (Preferred)
- Use your dermatology or aesthetics background (if applicable) to support training, sales education, and client account management.
Ideal Profile
What You Bring
- Proven Expertise: Extensive experience in regulatory affairs and quality assurance within the medical skincare or cosmetics industry.
- Knowledge of Regulations: Deep understanding of FDA, OTC, and international cosmetic/skincare compliance standards.
- Scientific Excellence: Expertise in formulation compliance, product testing, and stability studies to validate claims.
- Global Mindset: Ability to manage international compliance, ingredient substitutions, and regulatory documentation for global markets.
- Adverse Reaction Management: Familiarity with managing and reporting adverse reactions in compliance with regulatory requirements.
- Exceptional Communication: Strong English communication skills (written and verbal) for seamless collaboration with cross-functional teams.
- Preferred: Background in medical skincare or professional aesthetics/dermatology to enhance sales and education initiatives.
Ready to bring your expertise in regulatory affairs and quality assurance to a premium skincare leader? Apply today and help shape the future of this extraordinary brand—all while working remotely!
KINDLY APPLY HERE: https://wkf.ms/40mCjGc
What’s on Offer?
- Work alongside & learn from best in class talent
- A role that offers a breadth of learning opportunities
- Flexible working options