AXIS-Y

Global Regulatory Affairs Manager

Seoul, Seoul, KR

about 1 month ago
Save Job

Summary

As the Global Regulatory Affairs Manager, you will take full ownership of regulatory compliance from A to Z—executing product registration and post-market activities across all regions. This is not just a strategy role—you will directly manage and complete all regulatory submissions and documentation to ensure fast and smooth market entry.



Key Responsibilities


Global Compliance Execution (60%)

  • Directly Handle all aspects of cosmetic product regisration and compliance across:

-Americas: FDA (OTC/cosmetic), Health Canada, ANVISA

-EMEA: EU CPNP, UK SCPN, GCC (SASO), Turkey

-APAC: China NMPA, Korea MFDS, Japan MAFF, ASEAN CSRS

  • Prepare and submit regulatory dossiers, product information files, and safety assessments
  • Work independently with third-party consultants or authorities for complex markets (e.g., China, GCC)
  • Maintain registration status, renewals, and technical documentation with complete ownership


Regulatory Enablement for Market Growth (25%)

  • Execute market entry strategies aligned with commercial priorities
  • Lead response to regulatory audits, inspections, and inquiries
  • Monitor and interpret regulatory changes (e.g., MoCRA, EU Microplastics Ban) and adjust compliance strategies accordingly


Compliance Systems & Team Collaboration (15%)

  • Set up scalable digital tools to monitor global compliance in real time
  • Support cross-functional teams with clear guidance on claims, labeling, and documentation



Qualifications


  • 4+ years of direct experience in global cosmetics regulatory affairs
  • Proven success in end-to-end product registration for multiple regions (EU, China, US required)
  • Strong understanding of international regulatory frameworks and dossier preparation
  • Business fluency in English and Korean (spoken and written)
  • Self-starter with the ability to independently manage regulatory operations across multiple markets

How strong is your resume?

Upload your resume and get feedback from our expert to help land this job

People also searched: