Sr. Manager/Associate Director, Regulatory Program Management

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 seeking a Sr. Manager/Associate Director, Regulatory Program Management to support the Achondroplasia and related skeletal dysplasia regulatory team. This individual will partner closely with the Sr. Director, Program Management, SVP, Regulatory Affairs, and cross-functional team members to enable delivering on key regulatory and filing goals for the program. This position requires understanding of and experience in biotech/drug development, regulatory filings and project management for late-stage clinical programs. The ideal candidate will be developing leadership skills and will have exceptional attention to detail and organizational skills. The role requires someone who can organize projects effectively in a rapidly changing, fast-paced setting. We are looking for a self-starter that will help drive our achondroplasia program through to MAA and NDA filings and drive successful execution of our regulatory plans. Previous experience in a regulatory project management role within the pharmaceutical or biotech industry & experience with filings are a must.  

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 a treatment option to children living with Achondroplasia and their families. 

Responsibilities

• Work with the regulatory team to develop and maintain overall integrated project timelines across all regulatory deliverables, including NDA/MAA marketing application timelines
• Develop and maintain dashboards to identify and monitor critical items in preparation of global filings
• Develop and maintain timelines for pressure testing submission scenarios (i.e., base case, best case, and available data)
• Provide project management and logistical support for all agency interactions
• Proactively identify potential issues, constraints, bottlenecks, risks, gating items and mitigation management and escalates issues, as needed; propose solutions to support decision-making for the NDA/MAA
• Clearly and proactively communicate with leadership and program teams in a concise and timely manner: this can comprise written reports at desired cadence, visual aids/tracking systems to display progress and at-risk items for the NDA/MAA
• Assist team in scheduling regulatory cross functional meetings, capturing minutes, disseminating minutes and ensuring follow ups
• Ensure awareness, visibility and planning for regulatory submissions and effectiveness and efficien