Senior Director, Regulatory Affairs

Full-TimeQEDBrisbane, CARegulatory Affairs

Apply Now

QED Therapeutics, a subsidiary of BridgeBio Services, focuses on precision medicine for FGFR-driven cancers and diseases. The company’s first therapy, TRUSELTIQTM (infigratinib), is an orally administered FGFR1-3 tyrosine kinase inhibitor that the US FDA recently approved to treat patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement. We are also evaluating infigratinib for the treatment of other FGFR-driven cancers and the treatment of achondroplasia and other skeletal dysplasias. 

QED is derived from the Latin “Quod Erat Demonstrandum” —Thus; It Has Been Proven. Our values inspire our business:

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

FGFR=fibroblast growth factor receptor.

BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country. 

To learn more, 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 develop and execute global regulatory strategies aimed at the most efficient regulatory pathway for oncology drug and/or diagnostic development programs. This role involves collaboration with cross-functional project teams in planning development strategies and leading global regulatory submissions for assigned projects.
Responsibilities:
  • Serve as a critical regulatory team member with responsibility for regulatory strategies and submissions for assigned projects
  • Provide regulatory guidance and strategy for support of product development and registration strategies, including broad regulatory oversight for nonclinical/clinical development
  • Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA/IDE/PMA, as applicable) in compliance with all applicable regulatory requirements and alignment with corporate goals
  • Act as the primary liaison with regulatory authorities
  • Manage, direct and assist internal staff and regulatory consultants, as required, to ensure compliance of drug development activities with all U.S. and international requirements
  • Support due diligence and partnering activities, as needed
  • Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep the Company informed on any relevant changes in the regulatory landscape
  • Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations
Education, Experience & Skills Requirements:
  • BA/BS degree required in biological/physical sciences.  Advanced degree preferred
  • Minimum requirements are flexible, but ten years of minimum industry experience is generally required
  • Knowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and industry-standard practices
  • Experience in oncology required
  • Proven ability to think strategically
  • Proficient in written, oral, and interpersonal communications
  • Ability to manage complexity and uncertainty
  • Ability to work in a small/mid-sized company within a largely virtual environment; small biotech/pharma experience preferred
  • Experience working on programs with co-development partners
  • Embraces company core values:  1. put patients first; 2. think independently, 3. be radically transparent; 4. every minute counts; and 5. let the science speak
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
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Senior Director, Regulatory Affairs

Full-TimeQEDBrisbane, CARegulatory Affairs

Apply Now