Regulatory Consultant
Sculpted by Aimee
Regulatory Compliance & Risk Manager
Sculpted by Aimee
full-time
Posted on:
Location Type: Hybrid
Location: Dublin • 🇮🇪 Ireland
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
ERP
About the role
- Create and manage risk management frameworks, monitor regulatory changes, create policies, collaborate with various teams & communicate with stakeholders to implement controls, and promote a risk-aware culture.
- Operational Risk: Supply Chain – raw material shortages, logistics breakdown. Manufacturing – quality control failures, contamination, batch recalls. IT systems – e-commerce platform downtime, ERP downtime.
- Regulatory Risk: Cosmetics regulations – ingredient bans, safety testing. Advertising standards – misleading claims. ESG and sustainability – packaging waste regulations, carbon disclosures.
- Reputational Risk: Social Media, Data Privacy breaches.
- External & Environmental Risk: Macroeconomic, Geopolitical, Climate & Environmental.
- Ensure ongoing compliance with EU Cosmetics Regulation (EC) No. 1223/2009, Product Information File (PIF) and Cosmetic Product Safety Reports (CPSR). CPNP notifications and product submissions formulations, labels, and claims compliance with EU standards.
- Monitor regulatory changes and communicate updates to internal stakeholders. Lead preparation for HPRA Distributor and Responsible Person Audits.
- Lead compliance efforts with US FDA cosmetic regulations, including the Modernization of Cosmetics Regulation Act (MoCRA): facility registration and product listings with the FDA; labeling, claims, and ingredient declarations compliance; adverse event reporting & post-market surveillance; potential OTC drug classification risks for borderline products.
- Research and interpret cosmetic regulations in target expansion markets (e.g., Canada, Australia, Latin America, Asia, Middle East).
- Implementing and maintaining quality systems (e.g., GMP) to ensure consistent product quality and effective management of customer complaints or adverse event reporting.
- Overseeing product safety assessments and ensuring compliance with cosmetic safety regulations, toxicological requirements, and ingredient standards across global markets.
- Support sustainable business practices by minimizing waste, promoting responsible sourcing, and reducing environmental impact.
- Foster a diverse, inclusive, and ethical workplace while contributing to our community initiatives both internally and externally. Uphold integrity, transparency, and accountability in all business practices.
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Pharmacy, Chemistry, or related field.
- 4-5+ years of regulatory affairs experience in cosmetics, personal care, or related industries.
- Experience in FMCG risk frameworks covering operational, reputational, financial, and external risks.
- Familiarity with corporate governance, ESG risks, and external stakeholder management.
- Professional certifications in Risk Management, Business Administration, or Compliance will be advantageous.
- Strong knowledge of international cosmetic regulations (EU Cosmetics Regulation, FDA, ASEAN, etc.).
- Experience preparing and managing PIFs, CPSRs, and product notifications.
- Project management experience.
Benefits
- Health insurance
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairsrisk management frameworksquality systemscosmetic regulationsproduct safety assessmentsGMPPIF managementCPSR managementadverse event reportingproject management
Soft skills
communicationcollaborationleadershipstakeholder managementintegritytransparencyaccountabilitydiversity and inclusionethical practicescommunity initiatives
Certifications
Risk Management certificationBusiness Administration certificationCompliance certification