CMC Regulatory Affairs Scientist - Innovative Medicine

About the role

Johnson & Johnson is hiring a Scientist in its Innovative Medicine R&D group, within the CMC Sciences Regulatory Affairs function, based in Chiyoda, Tokyo. The role prepares CMC application dossiers and communicates with the Health Affairs (HA) department to help obtain regulatory approval, and manages change control of approved products. It sits under the Discovery & Pre-Clinical/Clinical Development function.

Key responsibilities

• Manage the team, supervise members and align resources and timelines to deliver activities on schedule
• Plan the Japan CMC regulatory strategy and the NDA strategy, aligned with the global post-marketing regulatory strategy
• Create pre- and post-approval CMC dossiers, including consultation documents, and ensure regulatory document compliance through accurate writing, review, QC and compliance checks
• Review CMC documents prepared by team members and give input
• Prepare and answer CMC questions from the PMDA and communicate directly with PMDA officials where necessary
• Handle change control of approved products and cope with GMP / compliance inspections by the PMDA
• Assess the impact of new or revised CMC regulations and implement necessary changes
• Take part in task forces, initiatives and external industry events

Required profile

• At least 5 years of experience in a CMC-related area in the pharmaceutical industry
• Familiarity with CMC regulatory notifications in Japan
• Experience completing NDAs in Japan, either as a CMC-RA representative or as a team leader, or experience in regulatory procedures in pharmaceutical research or CMC-related operations
• Bachelor's, Master's or Doctor of Science degree

Required skills

• Ability to discuss CMC regulatory topics with global colleagues in English
• Able to build trust with global members and government officials and to build consensus with team members
• Adaptability to IT and digital transformation