Manager/Senior Manager, Regulatory Affairs

Full-TimeQEDBrisbane, CARegulatory Affairs

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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 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 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:

Reporting to a Director of Regulatory Affairs, the Manager 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
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 enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
careers

Manager/Senior Manager, Regulatory Affairs

Full-TimeQEDBrisbane, CARegulatory Affairs

Apply Now