Regulatory Affairs Associate
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)