Position Summary:
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:
Change Control & Compliance Support:
Cross-functional Collaboration:
Process and Documentation Support:
Qualifications:
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.
World Courier
Sarpi Remediation Europe
World Courier
Lifelancer
Veeva Systems