This is a senior Quality Leadership role within an emerging company that is revolutionizing the treatment of serious and debilitating diseases through the commercialization of novel drug and cellular therapeutics leveraged by proprietary gene-based companion diagnostics.
The primary purpose of the Vice President of Regulatory Affairs position is to ensure worldwide regulatory strategies are clearly delineated, supported and implemented in the development, commercialization and life cycle management of the business’s Human Cell and Tissue Products (HCT/Ps).
The successful candidate will lead the development of global regulatory strategies and timelines for HCT/P product development projects, working through cross-functional teams to ensure that various pathways are examined early in the process. An assessment of the business risks associated with the preferred regulatory strategies, along with the mitigation plans must be presented to the project team and management in order to keep commercialization progress on track. You will also contribute to the preparation and submission of domestic 510(k), Instructional Review Board (IRB), Investigational New Drug Application (IND) and international regulatory filings for the business group in accordance with policies and procedures established by the company and regulatory agencies.
Qualification for the Vice President of Regulatory Affairs position include:
Benefits of the Vice President of Regulatory Affairs position include: