Associate Director, Regulatory Affairs

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.
 
Our business is inspired by our values:

• PUT PATIENTS FIRST
• LET SCIENCE SPEAK
• EVERY MINUTE COUNTS
• THINK INDEPENDENTLY
• BE RADICALLY TRANSPARENT

FGFR=fibroblast growth factor receptor.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Raleigh, and with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at https://www.qedtx.com/ | https://bridgebio.com 

Who You Are

We are looking for a talented and motivated regulatory affairs leader to help develop and execute regulatory strategies aimed at the most efficient regulatory pathway for development programs. This involves collaboration with cross-functional project teams in planning development strategies and leading global regulatory submissions for assigned projects. 

Responsibilities

• Develop and execute regional regulatory strategies in support of development programs. Provide regional regulatory guidance and strategy for support of product development and registration strategies, including broad regulatory oversight for nonclinical/clinical development  
• Represent Regulatory at cross-functional team meetings
• Lead study-related regulatory activities: 
  • Act as the regulatory study representative at cross-functional team meetings 
  • Provide strategic regulatory guidance internally on study-level decision-making 
  • Keep study team informed of regulatory activities in the context of study team management meetings 
  • Provide ownership of study-level global regulatory activities, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manage other regulatory aspects of the study as necessary
  • Manage tracking of regulatory/ethics submissions and approvals across all studies 
• Facilitate FDA or other Health Authority meetings in collaboration with Regulatory leadership
• Collaborate with Project Team representatives in the planning of regulatory documents; support processes by which regulatory submissions are reviewed, finalized, and signed-off
• Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses, and provide periodic status updates regarding unfulfilled conditions/commitments 
• Input to global regulatory submissions and strategic planning as applicable 

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with qualit