Associate Director, Regulatory Affairs

Full-TimeQEDBrisbane, CARegulatory Affairs

Apply Now

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, 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 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, Boston, New York, and Raleigh, 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:

Reporting to a Director of Regulatory Affairs, the Associate Director will support day-to-day regulatory activities of assigned projects.  These include supporting preparation and compilation of submissions for regulatory agencies, assigned clinical studies, management of regulatory submissions processes and timelines, and regulatory tracking tools, archives, and infrastructure, as assigned.
Responsibilities:
  • As the regulatory representative for assigned clinical studies, provide representation for study-level regulatory activities and updates in study team management meetings, support clinical trial application activities, review and approve investigator document packages including FDA submissions, and manage other regulatory aspects of the study as directed
  • 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
  • Collaborate with Project Team representatives in the planning of regulatory documents, including responses to Health Authority queries; support processes by which regulatory submissions are reviewed, finalized, and signed-off
  • Manage the tracking of regulatory/ethics submissions and approvals across all studies
  • Manage document archive processes

  • 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 towards 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 quality, precision, and speed
Education, Experience & Skills Requirements:
  • BA/BS degree in the biological or physical sciences preferred
  • Relevant pharmaceutical industry experience including experience in regulatory affairs; minimum requirements are flexible, but 3 years minimum industry experience is generally required
  • Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry-standard practices
  • Proficient in written, oral, and interpersonal communications in English
  • Ability to work in close collaboration with colleagues in the regulatory department and throughout the development organization
  • High attention to detail; ability to organize, prioritize, and delegate assigned projects
  • Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations preferred
  • Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems and document review tools desirable
What We Offer:
  • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
  • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
  • An unyielding commitment to always putting patients first. Learn more about how we do this here
  • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
  • A place where you own the vision – both for your program and your own career path
  • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
  • Access to learning and development resources to help you get in the best professional shape of your life
  • Robust and market competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
  • Flexible PTO
  • Rapid career advancement for strong performers
  • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
  • Partnerships with leading institutions
  • Commitment to Diversity, Equity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard
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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Associate Director, Regulatory Affairs

Full-TimeQEDBrisbane, CARegulatory Affairs

Apply Now