Manager/Senior Manager, Regulatory Affairs

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Job description

Who You Are:

We are looking for a talented and motivated regulatory affairs leader to help develop and execute global regulatory strategies aimed at the most efficient regulatory pathway for oncology drug and/or diagnostic development programs. This involves collaboration with cross-functional project teams in planning development strategies and leading global regulatory submissions for assigned projects.

Reporting to a Director of Regulatory Affairs, the Manager will support day-to-day regulatory activities of assigned oncology projects. These include support of preparation, compilation, and execution of submissions for regulatory agencies, assigned clinical studies, management of regulatory submission processes and timelines, and regulatory tracking tools, archives, and infrastructure, as assigned. This position will support two BridgeBio subsidiaries: QED Therapeutics and Navire Pharma (50%/50% split).

About Us:

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 for the treatment of 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 as well as for 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.

Navire Pharma, another subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on harnessing breakthrough discoveries in our understanding of SHP2 to address the large and growing unmet need in rare and difficult-to-treat cancers. Navire's team of veteran biotechnology executives are partnering with leading cancer experts to advance effective therapies to patients as rapidly as possible.

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 aim 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 | |

Responsibilities:

• As the regulatory representative for assigned clinical studies, you will:
• Provide ownership of study-level regulatory activities, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manages other regulatory aspects of the study as necessary
• Act as the regulatory study representative at cross-functional team meetings
• Provides regulatory guidance internally on study-level decision-making
• Keeps study team informed of regulatory activities in the context of study team management meetings
• Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, 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
• Support global regulatory submissions and strategic planning as applicable
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
• Three years minimum industry experience is generally required in the relevant pharmaceutical industry, including regulatory affairs
• 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.