BridgeBio Pharma, Inc. Regulatory Affairs Postdoctoral Research Fellow

Northeastern University • San Jose, CA

131d • $65,360 - $92,322

About The Position

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. 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.

Requirements

• Doctor of Pharmacy degree from an ACPE-accredited institution.
• Eligible for pharmacist licensure in the State of Massachusetts.
• Excellent oral and written communication skills.
• Strong time management and leadership abilities.
• Ability to work independently and take initiative on a variety of projects.

Responsibilities

• Manage, develop, and implement regulatory strategy in support of Eidos development programs.
• Develop proficiency within the Veeva regulatory management system to support the planning, preparation and execution of high-quality regulatory submissions.
• Develop and maintain knowledge of ICH, GCP, 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.
• Gain in-depth knowledge of labeling regulations regarding CCDS, USPI, SmPC, and 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 labeling, and labeling trends.
• Assist in preparation of responses to labeling-related queries from health authorities.
• Support regulatory review of promotional and non-promotional materials in accordance with business goals and objectives.
• Coordinate timely and accurate review of materials for submission to the FDA.

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• Paid time off
• Tuition assistance
• Wellness & life benefits
• Retirement benefits
• Commuting & transportation benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Ph.D. or professional degree