メディカル・バイオ - メディカルGQP・GMP・品質保証・品質管理
メディカル・バイオ - 品質管理

1. Oversight and lead regulatory CMC activities, including Partial Amendment Applications
(PAA), pre-approval GMP/QMS inspections, Foreign Manufacturer Accreditation/Registration
(FMA/FMR), Marketing Authorization (MA) Notifications, and Minor Change Notifications (MCN)
.
2. Prepare and review submission documents for assigned products including NDA/PAA/MCN,
ensuring alignment with customer needs and regulatory requirements.
3. Conduct comprehensive risk assessments and develop CMC strategies for assigned
products. under collaboration with the team to drive project success.
4. Engage in effective communication and/or negotiation with counterparts, e.x. global
regulatory affairs, product supply, external supplier, and health authorities to secure
approvals for assigned products. Build trust and foster open dialogue and collaborative
problem-solving.
5. Mentor less-experienced colleague in developing expertise by advising regulatory
processes, change assessments and CMC regulatory strategies.

■休日：完全週休二日制, 土, 日

• 5+ years-experience in areas of regulatory CMC and change management of marketed
products
• In-depth understanding of regulatory requirements, difference from overseas regulation and
processes related to CMC submissions, including familiarity with health authority interactions
• Sufficient experience in regulatory tasks to handle various CMC changes
• Proven experience of CMC documentation for submission with excellent working knowledge
of current electronic authoring, document management and electronic regulatory submissions
• Solid technical background, knowledge and understanding as a CMC specialist about one of
specialized area in CMC, e.g. chemistry, formulation, analytical science, or quality assurance
• Ability to prioritize regulatory change management within complex situations influenced by
multiple factors, and provide guidance to efficiently execute regulatory change management
• A proactive, creative mindset that embraces change and drives innovation within the team
• Ability to establish rapport with all key stakeholders with VACC leadership mindset

• Excellent verbal and written communication skills, with the ability to engage effectively with
stakeholders in Japanese / English (TOEIC 700 or more)

■職種未経験者：不可