Regulatory Manager Contractor - CMC

The Manager, Regulatory CMC is responsible for supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to the development and commercialization of the company’s product. This role works closely with cross-functional teams, including Manufacturing, Quality Assurance, Quality Control, and Research, to compile and maintain high-quality regulatory submissions.

The Manager will assist in the preparation of CMC content for INDs/CTAs and amendments, assess change controls for regulatory impact, and help ensure compliance with applicable US and global regulatory requirements. This position offers an excellent opportunity to grow in regulatory affairs within an innovative, fast-paced biotechnology environment focused on advanced therapies.

Responsibilities

Regulatory Documentation & Submissions:•    Contribute to the preparation, review, and coordination of CMC sections for global regulatory submissions, including INDs, CTAs, 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/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.

Qualifications

•    Bachelor’s or master’s degree in a scientific or engineering discipline (e.g., biology, chemistry, biochemistry, pharmaceutical sciences).•    5+ years of experience in Regulatory Affairs or related experience in Manufacturing, QA, or QC in a biotech/pharmaceutical environment.•    Exposure to CMC regulatory filings (INDs, CTAs, or amendments) preferred.•    Experience in cell or gene therapy is a plus, but not required.•    Understanding of the drug development process and the role of CMC in regulatory submissions.•    Familiarity with ICH guidelines and US/global regulatory requirements.•    Strong organizational and communication skills.•    Detail-oriented with a focus on quality and accuracy.•    Ability to manage multiple tasks and timelines in a dynamic environment.•    Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) and document management systems.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

ProKidney is a healthcare technology company specializing in developing innovative solutions for kidney disease management. With a commitment to revolutionizing renal care, ProKidney leverages cutting-edge technology and medical expertise to provide advanced tools and services that enhance patient outcomes and streamline healthcare processes in the field of nephrology.