Postdoctoral Research Fellow, BridgeBio--Regulatory Affairs

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 PharmD graduates. Critical to the success of the program is our ability to prepare Fellows to meet the ongoing workforce needs in various areas of industry.  

Our program gives fellows an opportunity to work with our innovative biopharmaceutical industry partners while collaborating with Northeastern University faculty in professional and career development, service, scholarship, and teaching. 

In partnership with Northeastern University, BridgeBio is offering a two-year Regulatory Affairs PharmD fellowship based in San Francisco, CA. 

About BridgeBio: 

BridgeBio Pharma Inc. (BridgeBio) 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. 

About Eidos Therapeutics, Inc. a BridgeBio Company 

Transthyretin (TTR) amyloidosis (ATTR) is a rare, underdiagnosed, and life-threatening disease with limited treatment options that can damage the heart and/or nervous system. BridgeBio’s mission is to improve the morbidity and mortality of patients with ATTR through the discovery and development of a novel therapeutic through its affiliate, Eidos Therapeutics. 

Responsibilities: 

Regulatory Strategy  

• Manage, develop, and implement regulatory strategy in support of Eidos development programs.   

• 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 including 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