Japan Regulatory Affairs Lead - Tokyo
1ヶ月前
Job summary
We are supporting a global life sciences organization in identifying an experienced Japan Regulatory Affairs Lead (CMC-focused). This role is responsible for defining and executing Japan-specific CMC regulatory strategies, ensuring compliance with Japanese regulations, and leading cross-functional regulatory teams across the product lifecycle.Responsibilities
- Act as the primary CMC Subject Matter Expert for Japan regulatory activities.
- Develop and execute CMC and GMP regulatory strategies in alignment with Japanese regulatory requirements.
- Lead change control evaluations, submission planning, and regulatory impact assessments.
- Ensure all submissions are prepared in full compliance with Japan regulations and guidance.
求人説明
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