BridgeBio- Regulatory Affairs Postdoctoral Research Fellow

NU USA Northeastern University; Palo Alto (CA); Vor Ort; USD 66.000 - 94.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits package

Zusammenfassung

Northeastern University, in partnership with Eidos and BridgeBio Pharma, offers a two-year Regulatory Affairs fellowship based in San Francisco. You will develop regulatory strategy, support labeling activities, and review promotional materials in collaboration with Clinical, Statistics, Medical Affairs, and Commercial teams.

The program focuses on Regulatory Affairs deliverables, with opportunities to contribute to broader clinical development and pharmacovigilance projects within the BBIO

Qualifikationen

• 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 at both the industry site and Northeastern.

Aufgaben

• Regulatory Strategy: develop regulatory strategy for Eidos development programs and familiarize with ICH, GCP, GMP guidelines.
• Global Labeling: support labeling strategy, CCDS, USPI, SmPC, SPL, and coordination with health authorities.
• Advertising & Promotion (MLR): review promotional materials and coordinate with cross-functional teams for submissions to FDA.

Kenntnisse

Excellent communication

Time management

Leadership abilities

Independent work

Ausbildung

Doctor of Pharmacy degree

Jobbeschreibung

About the Opportunity

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 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 labeling, and labeling trends and work with cross-functional team to ensure that the regulatory labeling strategy is aligned with the global regulatory strategy. Assist in preparation of responses to labeling-related queries from health authorities.

Advertising and Promotion (Medical, Legal, and Regulatory (MLR))

Support regulatory review of promotional and non-promotional materials in accordance with business goals and objectives, health authority regulations, ICH guidelines, Pharmaceutical Research & Manufacturers of Americans (PhRMA) guidelines, company policies and established precedents and recommend revisions/actions that achieve fair balance. Support the review and approval of promotional and non-promotional materials in a cross-functional promotional review committee that includes Commercial, Medical Affairs, and Legal. Coordinate timely and accurate review of materials for submission to the United States Food and Drug Administration (FDA).

Qualifications

• 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 at both the industry site and Northeastern

Additional Information

Applicants should submit the following application materials by the priority deadline of October 31, 2026:

• 1. Curriculum vitae (CV), uploaded
• 2. Unofficial PharmD transcripts, uploaded
• 3. Cover letter, uploaded

Letters of Recommendation Three formal Letters of Recommendation (LORs) must be submitted directly by the letter writers no later than November 23, 2026. Each letter writer must include: The candidate's full name The fellowship program(s) to which the candidate is applying (e.g., Smith, John – Alnylam, GSK)

Recommendations must be submitted directly by the recommender and cannot be submitted by the applicant. Address cover letter and letters of recommendation to: J. Andrew Orr-Skirvin, PharmD, BCOP Clinical Professor, Department of Pharmacy & Health Systems Sciences Pharmaceutical Industry Fellowship Program Director 360 Huntington Ave, 140 The Fenway R218 Boston, MA 02115 Northeastern University will not provide H-1B, TN, O-1, E-3, or any other type of employment visa sponsorship for the successful applicant to this position, now or in the future. STEM OPT is not compatible for this position. The successful applicant must be able to maintain valid work authorization in the United States throughout the entire appointment without Northeastern University's sponsorship for a visa.

Position Type Research Additional Information Northeastern University considers factors such as candidate work experience, education and skills when extending an offer. Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit https://hr.northeastern.edu/benefits/ for more information. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.

Compensation

Grade/Pay Type: 108S Expected Hiring Range: $66,345.00 - $93,712.50 With the pay range(s) shown above, the starting salary will depend on several factors, which may include your education, experience, location, knowledge and expertise, and skills as well as a pay comparison to similarly-situated employees already in the role. Salary ranges are reviewed regularly and are subject to change.

Northeastern University

Founded in 1898, Northeastern is a global research university and the recognized leader in experiential lifelong learning. Our approach of integrating real-world experience with education, research, and innovation empowers our students, faculty, alumni, and partners to create worldwide impact. Our global university system provides our community and academic, government, and industry partners with unique opportunities to think locally and act globally. The system—including 14 campuses across the U.S., U.K., and Canada, 300,000-plus alumni, and 3,000 partners worldwide—serves as a platform for scaling ideas, talent, and solutions. The university’s residential campuses for undergraduate and graduate degrees are located in Boston, London, and Oakland, California. Our research and graduate campuses are in the Massachusetts communities of Burlington and Nahant; Arlington, Virginia; Charlotte, North Carolina; Miami; Portland, Maine; Seattle; Silicon Valley, California; Toronto; and Vancouver. Northeastern’s personalized, experiential undergraduate and graduate programs lead to degrees through the doctorate in 10 colleges and schools across our campuses. Learning emphasizes the intersection of data, technology, and human literacies, uniquely preparing graduates for careers of the future and lives of fulfillment and accomplishment. Our research enterprise, with an R1 Carnegie classification, is solutions oriented and spans the world. Our faculty scholars and students work in teams that cross not just disciplines, but also sectors—aligned around solving today’s highly interconnected global challenges and focused on transformative impact for humankind.