The Program Manager, Regulatory Affairs manages the regulatory aspects of biotechnology-derived products, including applications submitted to the FDA and other regulatory agencies. This individual will lead the US Regulatory Affairs program for development of multiple cell-based products through the clinical phases and submission of a Biologics Licensing Applications (BLA). This includes leading the preparation and submission of Investigational New Drug (IND) and BLA applications, with overall responsibility for submissions and writing of Chemistry Manufacturing Controls (CMC) sections.
Working with cross functional collaborators (such as R&D and Quality) and external consultants, this individual will also advise on regulatory and scientific issues related to the development of these products. Must have proven experience with successfully leading and writing submissions and expertise in regulatory scientific aspects of biotechnology-derived products, specifically with a focus on CMC requirements.
ABILITIES AND SKILLS REQUIRED:
Strong oral and written communication skills, and negotiation skills
Willing to set and drive aggressive project timelines
Capable of strategic thinking and proposing innovative solutions to regulatory problems
A team player, who listens effectively
Bachelor’s degree in a scientific discipline
At least 10 years' experience in the medical or life science industry with at least five years of increasingly responsible experience in Regulatory Affairs
Solid working knowledge of device/biologic development process and of FDA regulatory requirements for biotechnology products in the U.S. required
Must have successfully submitted regulatory filings to the FDA and other regulatory agencies. Experience working on INDs and BLA submissions strongly preferred
Experience with technical aspects of product development and manufacturing
Internal Number: 326
Organogenesis is a leading regenerative medicine organization focused on empowering healing through the development, manufacturing and sale of products for the advanced wound care, surgical and sports medicine markets. We are committed to provide an integrated portfolio of healing solutions that improve lives while lowering the overall cost of health care. We empower clinicians with the full range of products and tools they need to heal patients and achieve better health outcomes.