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.

Key Responsibilities:

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

Preferred Qualifications:

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

Full time, Currently hiring,

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