Innovative Medicine R&D Principal Scientist CMC Group CMC Sciences Regulatory Affairs
Global healthcare company operating Innovative Medicine and MedTech businesses, including a robotic-assisted bronchoscopy platform.
About Johnson & Johnson
Johnson & Johnson develops medicines, therapies, medical devices and health technologies across oncology, immunology, neuroscience, cardiopulmonary, cardiovascular, orthopaedics, surgery and vision.
Skills
Candidate Availability
Required and preferred rules are kept separate and reflect the wording in the original posting.
About the Role
You will prepare and manage pre- and post-approval CMC dossiers, consultation documents, and regulatory responses in Japan. You will develop CMC regulatory strategies, communicate with PMDA officials, manage approved-product changes, ensure document compliance, supervise team members, and contribute to cross-functional and external initiatives.
Requirements
- At least 7 years of experience in a CMC-related pharmaceutical-industry role
- Familiarity with CMC regulatory notifications in Japan
- Experience completing Japanese NDAs as a CMC regulatory representative or team leader, or experience in pharmaceutical research or CMC regulatory procedures
- Ability to discuss CMC regulatory topics in English with global members
- Bachelor's, master's, or doctorate degree in science
Responsibilities
- Lead CMC regulatory activities at team meetings and support product development and lifecycle management
- Supervise team members and manage resources and timelines
- Develop Japan CMC regulatory and NDA strategies
- Create pre- and post-approval CMC dossiers and consultation documents
- Review CMC documents and ensure regulatory document compliance
- Prepare responses to PMDA questions and communicate with PMDA officials
- Manage change control for approved products
- Support PMDA GMP and compliance inspections
- Assess new or revised CMC regulations and implement required changes
- Participate in task forces and external industry activities