Northeastern University · 4 months ago
BridgeBio Pharma, Inc. Regulatory Affairs Postdoctoral Research Fellow
San Jose, CA
Full-time
Onsite
New Grad, Entry Level
$65K/yr - $92K/yrNortheastern University is offering a two-year Regulatory Affairs Postdoctoral Research Fellowship in partnership with BridgeBio Pharma, Inc. This role involves managing and developing regulatory strategies for Eidos development programs, supporting regulatory submissions, and engaging with cross-functional teams to ensure compliance with global guidelines.
Education
Responsibilities
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
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
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)
Qualification
Required
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
Benefits
Medical
Vision
Dental
Paid time off
Tuition assistance
Wellness & life
Retirement-
Commuting & transportation
Company
Northeastern University
Founded in 1898, Northeastern is a global research university with a distinctive, experience-driven approach to education and discovery.
Founded in 1898
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Angela Hosking
CEO Regional Dean
Dave Thurman
Dean & CEO, Seattle Campus
Recent News
2024-01-06
Alfred P. Sloan Foundation
2023-10-30
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