Jobs in Japan
Explore hand-picked jobs in Japan for English speakers across tech, education, marketing, and more.
Vetted companies only. Apply from overseas.
Explore hand-picked jobs in Japan for English speakers across tech, education, marketing, and more.
Vetted companies only. Apply from overseas.
Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Position Summary - To prepare application dossiers for CMC part and to communicate with HA appropriately to contribute in obtaining regulatory approval. - To conduct change control of approved products appropriately. Specific Tasks and Job Duties - Manage Team management - Fulfill CMC-RA responsibilities at team meetings and contribute to compound development / product lifecycle management - Supervises members, manage resources and timelines to deliver activities on schedule. - CMC-RA strategy planning / alignment - Identifies and inputs relevant Japan CMC regulatory information required to develop global CMC-RA strategy at the project initiation. - Develop Japan CMC-RA NDA strategy - Align to the product’s global post-marketing regulatory strategy. - CMC dossier management - Creates pre- / post- approval CMC dossiers including consultation documents. - Ensure regulatory document compliance through appropriate document preparation including accurate writing, review, QC, and compliance checks. - Reviews CMC documents prepared by team members and provides valuable input. - Implement regulatory procedures - Prepares and answers to CMC questions from PMDA, and communicate directly with PMDA officials where necessary. - Handles change control of approved products - Copes with GMP / compliance inspection by PMDA - Management of regulatory changes in Japan - Assesses the impact of new / revised CMC regulations and implements necessary changes - Contribute through task force / external activities - Participates in task forces/initiatives, collaborating with team members, as well as global and cross functional stakeholders to achieve continuous improvement. - Participates in external events or industry activities and makes a positive impact.
- At least 7 years’ experience in CMC related area in pharmaceutical industry - Familiar with CMC regulatory notifications in Japan - Experience of completing NDAs in Japan either independently as a CMC-RA representative or as a team leader or Experience in regulatory procedures in pharmaceutical research / CMC-related operations
- Benchmarking - Coaching - Consulting - Corporate Governance - Critical Thinking - Drug Discovery Development - Fact-Based Decision Making - Healthcare Trends - Interpersonal Influence - Organizing - Public Policies - Regulatory Compliance - Regulatory Development - Scientific Research - Strategic Thinking - Subject Matter Experts (SME) Collaboration - Technical Writing
