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Senior Director, Regulatory Affairs San Francisco, CA/Hybrid

Company: BridgeBio Pharma
Location: San Francisco
Posted on: March 20, 2023

Job Description:

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, TRUSELTIQ (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 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. The Senior Director, Regulatory Affairs, will drive global regulatory strategies and responsibilities across select BridgeBio Affiliate companies to successfully advance assets in succinct timelines. Responsibilities include developing and implementing regulatory strategies, interfacing with regulatory agencies, identifying and managing regulatory risks, implementing the regulatory aspects of clinical trials, and developing and submitting regulatory documents. This role will serve as the primary point of contact for regulatory agencies globally, with responsibility for regulatory agency submissions, action items, and communications worldwide on assigned programs. Responsibilities

  • Lead the creation and execution of proactive regulatory strategies for product development, approval, and registration
  • Apply knowledge of global quality/regulatory standards and guidelines to ensure requirements are met across programs
  • Partner with internal senior leadership to align closely on cross-functional global regulatory plans and the company's short and long-term strategic objectives
  • Lead regulatory submission deliverables
  • Prepare and implement critical global regulatory submissions (from pre-IND to post-marketing) to the FDA, EMA, and other international health authorities
  • Develop and present regulatory strategies, recommendations, and risks during senior management discussions
  • Lead the specific Affiliate regulatory strategy team by managing, mentoring, and teaching capabilities
  • Work at both high-level strategic and hands-on in leading an agile team 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 toward 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
    • Bachelor's degree in the scientific field is required; an advanced degree (MD, Ph.D., PharmD, MS) is preferred
    • A minimum of 10+ years of relevant pharmaceutical/biotechnology regulatory affairs experience in the pharmaceutical industry, including experience managing matrixed teams
    • Well-versed in the drug development process and regulatory requirements, as well as a good understanding of the underlying science
    • Strong attention to detail
    • Excellent written and verbal skills
    • Excellent project management skills, with the ability to manage multiple projects and prioritize appropriately
    • Ability to rapidly understand & analyze complex problems/situations
    • Ability to lead teams under tight timelines and be willing to contribute significantly to day-to-day operations as needed
    • Comfort in a team environment
    • Strong interpersonal skills and the ability to effectively work with others
    • Ability to influence without authority, lead change, and manage resistance to change
    • Ability to solicit information, persuade others, and shape outcomes
    • Experience working with all levels of management and consulting with key business stakeholders (internal and external) 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 To view San Francisco County's Fair Chance Ordinance, please click here .

Keywords: BridgeBio Pharma, San Francisco , Senior Director, Regulatory Affairs San Francisco, CA/Hybrid, Executive , San Francisco, California

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