01 feb
Select Assistants
Ciudad de México
Are you a compliance-driven professional with expertise in skincare regulations and a passion for innovation? Join a premium medical skincare brand that has been shaping the industry for over 30 years. As a Regulatory Affairs and Quality Assurance Manager, you’ll play a critical role in ensuring regulatory excellence, driving product compliance, and supporting global expansion—all from the comfort of your home.
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
1. Ensure all products meet international skincare regulations by managing product registrations and maintaining compliance documentation.
2. Lead the charge on FDA oversight, ensuring products align with OTC and cosmetic standards.
Product Testing & Claims Validation
1. Oversee clinical and stability testing to validate product claims and determine the need for long-term studies.
2. Guarantee that all product claims are scientifically substantiated.
International Compliance & Market Entry
1. Manage global regulatory requirements, including ingredient restrictions, packaging guidelines, and product classification, to facilitate smooth international expansion.
2. Stay ahead of the curve with market-specific regulations to streamline entry into new regions.
CMO & R&D; Coordination
1. Collaborate with contract manufacturers (CMOs) and R&D; teams to ensure formulations align with regulatory standards.
2. Drive production feasibility, supplier negotiations,
and ensure seamless alignment between innovation and compliance.
Ingredient Reformulation & Compliance
1. Evaluate regulatory implications for reformulated products, ensuring ongoing compliance with OTC regulations and market standards.
Product Ownership & IP Management
1. Maintain meticulous records of formulations, testing protocols, and product registrations to secure seamless manufacturer transitions and safeguard intellectual property.
Adverse Reaction & Quality Complaints Management
1. Manage and track adverse reactions reported by users, ensuring timely reporting and appropriate regulatory responses.
2. Oversee the resolution of quality complaints and implement improvements to prevent future issues.
Batch Record Management
1.
Handle batch record reviews to ensure manufacturing processes meet regulatory and quality standards.
2. Maintain accurate and thorough records to ensure compliance and facilitate smooth audits.
Education & Sales Support (Preferred)
1. Use your dermatology or aesthetics background (if applicable) to support training, sales education, and client account management.
Ideal Profile
What You Bring
1. Proven Expertise: Extensive experience in regulatory affairs and quality assurance within the medical skincare or cosmetics industry.
2. Knowledge of Regulations: Deep understanding of FDA, OTC, and international cosmetic/skincare compliance standards.
3. Scientific Excellence: Expertise in formulation compliance, product testing, and stability studies to validate claims.
4. Global Mindset: Ability to manage international compliance, ingredient substitutions, and regulatory documentation for global markets.
5.
Adverse Reaction Management: Familiarity with managing and reporting adverse reactions in compliance with regulatory requirements.
6. Exceptional Communication: Strong English communication skills (written and verbal) for seamless collaboration with cross-functional teams.
7. 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?
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Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.