Regulatory Manager Contractor - CMC
ProKidney(3 days ago)
About this role
The Manager, Regulatory CMC supports the regulatory activities related to the development and commercialization of biotechnological products, working closely with various departments to ensure regulatory compliance and effective documentation for global submissions. The role provides growth opportunities within a fast-paced biotech environment focused on advanced therapies.
Required Skills
- Regulatory Writing
- CMC
- INDs
- CTAs
- Change Control
- Regulatory Submissions
- ICH Guidelines
- Documentation
- Compliance
- Biotechnology
Qualifications
- Bachelor’s or Master’s Degree in Science or Engineering
- 5+ Years Regulatory Experience
- Experience with CMC Regulatory Filings
About ProKidney
prokidney.comProKidney is a late clinical‑stage biotechnology company developing a first‑in‑class cell therapy candidate to treat advanced chronic kidney disease (CKD). Their lead program aims to preserve kidney function in patients who have limited therapeutic options and to transform the therapeutic landscape for progressive CKD. As a pioneer in CKD therapeutics, ProKidney is advancing clinical development to demonstrate safety and efficacy of regenerative approaches. The company focuses on addressing a major unmet need in kidney disease through novel cell‑based treatments.
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