メディカル・バイオ - ＣＭＣ薬事

As the CMC lead at This Company, this role ensures timely delivery of qualified drugs by driving regulatory approvals for new products and updating commitments for marketed products through CMC variations.
It develops regulatory strategies, manages high‑quality submissions and responses, collaborates cross‑functionally, and engages proactively with health authorities while monitoring regulatory trends.
The role also maintains efficient regulatory processes, systems, and product registration databases to support accurate, timely submissions and approvals.

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始

Bachelor's degree or above in pharmacy or related science. Master’s degree is preferred.
More than 5 years of regulatory affairs related experience in pharmaceutical or biotech industry.
Knowledge and experience of CMC related regulations (incl. new chemical entities (NCE), biologics).
Working experience with multinational companies is preferred.
Requires excellent written and verbal communications in Japanese and business level communications in English.

■職種未経験者：可