Associate Director, Regulatory Affairs San Francisco, California, United States
About the position 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. 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. 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. Requirements • BA/BS degree in the biological or physical sciences. Advanced degree preferred. • Relevant pharmaceutical industry experience, including experience in regulatory affairs; a minimum of 5 years of 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 communication in English. • Ability to work in close collaboration with colleagues in the regulatory department and throughout the development organization. • Capability to provide strategic guidance on regulatory and program-related issues. • Ability to problem solve unexpected problems or roadblocks that arise. • 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. Benefits • 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. • A de-centralized model that enables our program teams to focus on advancing science and helping patients. • 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. 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