Regulatory Affairs Associate

Japan, Sagamihara

Key responsibilities:

Capture regulatory evolutions, documented via a pragmatic impact assessments and centralized in an overview database.  Translate applicable regulations or guidelines into comprehensive action plans and ensure proper implementation.

  • Maintain relevant documentations (SOPs, Validations, Quality Agreement, License, Cert, etc.) as part of the quality system and regulatory requirements
  • Maintain DMS (Document Management System) and Implement Corporate document
  • Organize Validation program, internal audit, Site Master File, approved supplier list
  • Maintain Master File, BSE Cert, ISO Cert, Halal Cert, Kosher Cert, HACCP Cert
  • Assess local change requests, global quality alerts for regulatory impact and follow-up on related regulatory action items
  • Conduct GMP / ISO trainings to employees
  • Support hosting GMP inspections, Certified body audits, Customer audits and Corporate audits
  • Support conducting supplier audit / assessment
  • Support customers and authority requests with the aim to increase Customer Satisfaction and regulatory compliance
  • Providing professional and satisfactory solutions to any customer / authority requests related to quality standards and regulations
  • Support internal customers like production, supply chain, sales, marketing, R&D, QA and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives by preparing Japan regulatory assessments for relevant regulatory topics of interest
  • Resolving personnel issues and workplace conflicts
  • Ensure compliance with global and local regulations / standards such as GMP / QMS, IPEC and ISO
  • Perform any other duties as assigned by your manager

Key requirements:

  • Bachelor degree and / or advanced graduate degree in Pharmacy (preferred), Chemistry, Biology or equivalent Science Field
  • Working experience in regulatory affairs or in quality assurance in the pharmaceutical or the food industry
  • Knowledge of GMP / QMS, IPEC, ISO, other regulations / standards
  • Knowledge of qualifications and validations
  • Knowledge of Data Integrity
  • Good Written & Oral Communication skill in Japanese (fluent level) and English (business level)
  • Skillful knowledge of Microsoft Windows and Microsoft Office (Excel, Word, PowerPoint, etc)
Reference: R41248