职责描述:
We are a fast-growing baby consumables brserving global markets across US,EU, UK, CA, APAC, rest of the world. Our portfolio includes Baby diapers, pants, wipes. As regulatory landscapes tighten — from EU REACH/Cosmetics Regulation updates to US FDA modernization APAC national standards evolution — we need a seasoned Regulatory Manager to safeguard market access, protect consumer trust, drive compliant innovation.
Key Responsibilities
1. Regulatory Strategy & Market Access
Develop maintain a regulatory roadmap fall target markets (US, CA, EU, UK, Australia, Middle East, ASEAN,etc).
Conduct regulatory gap analyses fnew product launches, formula changes, format innovations.
Advise Product Development Marketing on permissible claims, ingredient restrictions, labeling requirements before concept lock.
Manage market-specific registration/notification obligations (e.g., EU Cosmetics Portal notification, US FDA listing, Australian NICNAS/ACCC reporting, GCC standard certifications).
2. Product Compliance & Ingredient Governance
Review approve all raw material specifications, ingredient declarations, Safety Data Sheets before production.
Maintain an internal ingredient whitelist/blacklist aligned with EU REACH, CLP, Cosmetics Regulation (EC 1223/2009), US CPSIA, FDA GRAS, relevant national standards.
Oversee Safety Assessments (CPSR fEU cosmetics-grade baby products; toxicological risk assessments fdiaper materials).
Coordinate with external testing labs fdermatological testing, sensitization studies, heavy metal screening, microbiological challenge tests.
3. Labeling, Claims & Packaging Compliance
Ensure all on-pack text, symbols, warnings, claims meet market-specific regulations (EU Labelling Directive, UK GPSR, US FPLA, Australian Consumer Law).
Review advertising materials, digital content, influencer copy fregulatory conformity.
Manage multilingual label adaptations coordinate translations with regulatory precision.
4. Post-Market Surveillance & Incident Management
Work with quality team on the investigation of consumer complaints related to skin irritation, allergic reactions, product defects — root cause analysis, batch traceability, corrective action.
Manage RMP (Risk Management Plan) updates PIF (Product Information File) maintenance fEU-notified products.
Coordinate with distributors, FBOs (Feed/Business Operators), local agents on mandatory reporting obligations.
Prepare Rapid Alert notifications (RAPEX/Safety Gate) when required; liaise with competent authorities.
5. Standards & Certifications
Track evolving standards: EN ISO 9001, EN 13432 (compostability where applicable), ASTM standards fbaby products, ISO 10993 (biocompatibility fskin-contact materials).
Maintain OEKO-TEX, Dermatest, EWG, other voluntary certification programs.
Manage third-party audits regulatory inspections; prepare documentation packages.
6. Internal Governance & Training
Develop SOPs fregulatory review gates, complaint handling, change management.
Conduct regulatory awareness training fR&D,Quality, Marketing, Procurement, Customer Service teams.
Maintain a centralized regulatory database / compliance tracker with audit-ready documentation.
任职资格:
1.Bachelors degree in Chemistry, Toxicology, Biomedical Science, Pharmaceutical Sciences, related field. Masters preferred.
2.5–8 years in regulatory affairs within baby/infant consumables, personal care, cosmetics, medical devices (skin-contact).
3.Fluent English.
4.Cross-functional communication, crisis composure, detailientation, ability to translate regulation business action.