Job Description

Join I Peace – Help Shape the Future of Regenerative Medicine

I Peace is a biotech startup leading innovation in personalized and regenerative medicine using iPSC technology. We manufacture and sell GMP-grade iPSC products and are preparing for clinical trials with iPSC-derived cell therapy products.We are currently hiring for a key role in Chemistry, Manufacturing, and Controls (CMC) Manager with a focus on FDA interactions.

• Lead the preparation of materials for FDA Pre-IND and INTERACT meetings, including regulatory strategy, technical data summaries, and Q&A documents
• Coordinate with cross-functional teams (CMC, QA/QC, R&D) to ensure accurate and timely regulatory submissions
• Support clients with regulatory filings such as INDs
• Develop and maintain Drug Master Files (DMF)
• Manage internal QMS and ensure compliance with 21 CFR 210/211 and ICH Q7
• Communicate regulatory requirements and product compliance effectively to external clients

• 5+ years of experience in Quality Assurance or Regulatory Affairs, including 3+ years in cell or gene therapy
• Hands-on experience preparing documentation for FDA Pre-IND or INTERACT meetings
• Strong understanding of GMP and regulatory compliance for biological products
• Ability to work across U.S. and Japan teams and manage external consultants
• Experience in client-facing regulatory communication and support

If you thrive in a venture environment and enjoy taking on new challenges, this is the perfect opportunity. At I Peace, we live by the philosophy: "We will either find a way or make one." We’re looking for a like-minded professional to join us on our mission.

Industry: Biotechnology Research

Employment Type: Full-time

If you or someone you know may be a good fit, we’d love to connect.

Job Tags

Similar Jobs