💼 About This Role

You'll lead CMC regulatory strategies for rare disease products in Japan, collaborating with global teams. Your work will ensure compliance and drive submissions for clinical trials and marketing approvals. This role offers the chance to make a meaningful impact in a supportive, patient-focused environment at a growing biopharma company.

🎯 What You'll Do

• Develop and execute CMC regulatory strategies for assigned programs.
• Coordinate and manage global regulatory CMC submissions.
• Provide regulatory advice on change controls and comparability assessments.
• Maintain archive tracking regulatory CMC commitments and status.
• Serve as Japan Regulatory CMC point of contact for cross-functional teams.

📋 Requirements

• BA/BS in scientific field with 8+ years regulatory experience in pharma/biotech.
• Strong knowledge of biological drugs and regenerative medicinal product regulations.
• Proven ability to analyze and organize information logically.
• Excellent written and verbal English and Japanese communication skills.

✨ Nice to Have

• Experience with CTN, NDA, PCA, MCN submissions in Japan.
• Startup or fast-paced environment experience.

🎁 Benefits & Perks

• 🏥 Health insurance and wellness programs
• 🏖️ Paid time off and holidays
• 📈 Professional development opportunities
• 🤝 Collaborative and inclusive culture

🚩 Heads Up

• Role uses vague terms like 'ultra focused' and 'be a hero'.
• Requires both English and Japanese fluency, which may limit candidates.
• Mixed responsibilities between strategic and operational tasks.