Regulatory Affairs Program Manager

Our client is a biotechnology and regenerative medicine company that discovers, develops, and delivers innovative biotherapies. They have an immediate opening for a highly motivated person interested in joining their Liver Team in a fast-paced, team and results-oriented work environment. As the Regulatory Affairs Program Manager, you will implement regulatory and strategic business requirements into whole organ program requirements including but not limited to, advising on applicable testing, managing documentation needs and timelines, and support, preparation, and execution of regulatory submissions. This program management role will focus on support for the liver whole organ regenerative medicine program taking a bioengineered liver from pre-clinical to first-in-human trials and ultimately a biological license application. The novelty of this regenerative medicine product will require flexibility, extrapolation, and a willingness to come up with and consider a broad spectrum of novel regulatory needs and solutions. You will need to leverage your existing biologics knowledge but not be confined to box-checking as we move into areas not directly contemplated by regulatory authorities. In this role, you will have primary program management responsibility for the whole bioengineered liver program, a completely novel human cell, tissue, and cellular and tissue-based product. You will need to collaborate cross-functionally to facilitate and meet all regulatory and business objectives within stated timelines. This role is a once-in-a-lifetime opportunity for the right regulatory professional to help hundreds of thousands of patients, by bringing a paradigm-changing, history-making human cell, tissue, and cellular and tissue-based therapeutic to market. What Youll Be Doing: Appropriately implement FDA regulations to ensure the compliant development and approval of biologic products. Develop, modify, and execute regulatory policies that affect immediate and future operations. Defining and executing tactical implementation plans working directly with the development team. Develop strategies and produce detailed regulatory plans and submissions including Pre-IND, IND, BLA and special designation requests. Effectively communicate regulatory needs to cross functional teams supporting biologic development and regulatory submission. Coordinate testing required to support regulatory approvals. Facilitate, prepare, and participate in meetings with regulatory agencies. Work closely with Clinical Specialist Medical Writers to direct writing needs including content and format. What You Have: Bachelors Degree (Masters or Ph.D. preferred) Minimum 8 years of biologic or pharma regulatory experience Minimum 5 years of project/people management experience Personal experience with successful regulatory submissions Proficient knowledge of FDA regulations, especially 21 CFR 1271 and 21 CFR 312