BridgeBio-- Regulatory Affairs Postdoctoral Research Fellow at Northeastern University in San Jose, CA

Job description

About the Opportunity About the Opportunity Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.D. graduates. A key element of the program’s success is preparing Fellows to meet evolving workforce needs across various sectors of the pharmaceutical industry. Fellows have the opportunity to work closely with our innovative biopharmaceutical industry partners, while engaging with Northeastern University faculty in professional and career development, teaching, service, and scholarly activities. In partnership with Northeastern University, Eidos, a BridgeBio Pharma, Inc. Affiliate is offering a two-year Regulatory Affairs fellowship, based in San Francisco, California. About About Eidos and BridgeBio Pharma Inc. BridgeBio Pharma, Inc. (BridgeBio/BBIO) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers, and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. BridgeBio exists to bring meaningful medicines to patients as quickly and as safely as possible. We’re passionate about fostering open and transparent relationships with patients and their families by staying connected, listening to their experiences, and applying their insights into our work. We hope that by developing these relationships with patients, families, and patient advocacy organizations early in the development phase of our therapies that we can also craft our clinical trial protocols with the patient experience at the forefront. Eidos is an affiliate that operates under the BridgeBio umbrella. We are focused on the treatment of ATTR-CM, and our product, Acoramidis (marketed as Attruby), which recently received FDA approval in November 2024. While the fellowship position will be focused on Regulatory Affairs deliverables for Eidos, there may be opportunities to contribute to projects within other functional areas, e.g., clinical development, pharmacovigilance, etc. and/or other projects that are being led by other BBIO affiliates. Responsibilities Regulatory Strategy Manage, develop, and implement regulatory strategy in support of Eidos development programs. Develop proficiency within the Veeva regulatory management system where you will support the planning, preparation and execution of high-quality regulatory submissions (e.g. Clinical Trial Application (CTA)/Investigational New Drug (IND) application and amendments, annual reports, initial license applications (New Drug Application (NDA)/Marketing Authorization Application (MAA), etc.) and supplements/variations). Develop and maintain knowledge of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and other relevant global guidelines to ensure compliance of regulatory strategies and submissions. Work in cross-functional teams with members from Clinical, Statistics, Medical Affairs, Commercial, and Nonclinical groups to help operationalize regulatory strategy. Support regulatory interactions with regulatory bodies including preparation of meeting requests and briefing documents. Global Labeling Gain in-depth knowledge of labeling regulations regarding Company Core Data Sheet (CCDS), US Package Insert (USPI), Summary of Product Characteristics (SmPC), and Structured Product Labeling (SPL). Support development of regulatory labeling strategy and the negotiation and maintenance of competitive labeling with global health authorities. Maintain core labeling documents. Provide strategic guidance on labeling regulations, competitor label