Regulatory Manager, CMC (Chemistry, Manufacturing & Controls)

About This Role

ProKidney is seeking a Regulatory Manager specializing in CMC (Chemistry, Manufacturing, and Controls) to support regulatory activities for innovative cell and gene therapy development. This contractor position offers the opportunity to advance your career in regulatory affairs within a fast-paced biotechnology environment focused on advanced therapeutics. You will work collaboratively with cross-functional teams to ensure high-quality regulatory submissions and compliance with global standards.

Key Responsibilities

Regulatory Documentation & Submissions:

• Contribute to the preparation, review, and coordination of CMC sections for global regulatory submissions, including INDs (Investigational New Drug applications), CTAs (Clinical Trial Applications), and amendments
• Assist with compiling technical data from Manufacturing, QA, and QC teams to support submissions
• Maintain and track regulatory submission timelines and deliverables
• Support responses to health authority information requests related to CMC topics

Change Control & Compliance Support:

• Review and assess change controls to determine potential regulatory impact and filing requirements
• Maintain awareness of relevant regulatory guidance, ICH guidelines, and agency expectations for cell and gene therapies
• Help ensure documentation and submissions meet current regulatory standards and internal quality requirements

Cross-Functional Collaboration:

• Collaborate effectively with cross-functional partners in Process Development, Manufacturing, QA, QC, and Regulatory Affairs
• Participate in project team meetings and provide CMC regulatory support under the guidance of senior regulatory staff

Process and Documentation Support:

• Assist with developing or revising SOPs, working instructions, and templates used in Regulatory CMC activities
• Participate in the organization of regulatory archives and tracking systems for submission history and regulatory documentation

Required Qualifications

• Bachelor's or Master's degree in a scientific or engineering discipline (e.g., biology, chemistry, biochemistry, pharmaceutical sciences)
• 5+ years of professional experience in Regulatory Affairs or related experience in Manufacturing, QA, or QC within a biotech or pharmaceutical environment
• Understanding of the drug development process and the role of CMC in regulatory submissions
• Familiarity with ICH guidelines and US/global regulatory requirements
• Strong written and verbal communication skills with the ability to work effectively across teams

Preferred Qualifications

• Direct exposure to CMC regulatory filings (INDs, CTAs, or amendments)
• Experience in cell therapy or gene therapy development
• Knowledge of advanced therapy modality regulatory pathways

💰 Compensation not publicly listed. Market estimate for similar roles: from $200K, varying by experience and location.