Director of Regulatory Affairs

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Navire Pharma and QED Therapeutics are subsidiaries of BridgeBio Pharma.

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.

Navire 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. To learn more, visit us at: https://navirepharma.com/
With singular focus,

QED Therapeutics is devoted to the development of our investigational candidate, infigratinib. A first-in-class, selective, fibroblast growth factor receptor 2 (FGFR2)-inhibitor, infigratinib has promising early clinical data in patients with previously treated, FGFR-driven cholangiocarcinoma and metastatic urothelial carcinoma, as well as preclinical studies in achondroplasia. Future studies will investigate infigratinib for additional FGFR-driven tumor types and rare disorders. To learn more, visit us at: https://qedtx.com/

Who You Are:

We are looking for a talented and motivated regulatory affairs leader to 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.

Location

San Francisco, CA

Responsibilities

  • Serve as key regulatory team member with responsibility for regulatory strategies and submissions for assigned projects
  • Provide regulatory guidance and strategy for support of product development and registration strategies, including broad regulatory oversight for nonclinical/clinical development
  • Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA/IDE/PMA, as applicable) in compliance with all applicable regulatory requirements, and in alignment with corporate goals
  • Act as the primary liaison with regulatory authorities
  • Direct and assist internal staff and regulatory consultants, as required, to ensure compliance of drug development activities with all U.S. and international requirements
  • Support due diligence and partnering activities, as needed
  • Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep company informed on any relevant changes in the regulatory landscape
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations 

Education, Experience & Skills Requirements

  • BA/BS degree required in a biological/physical sciences. Advanced degree preferred
  • 5+ years regulatory affairs experience in the biotech or pharmaceutical industry
  • Knowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and industry standard practices.
  • Experience in oncology required
  • Proven ability to think strategically
  • Proficient in written, oral, and interpersonal communications
  • Ability to manage complexity and uncertainty
  • Ability to work in a small company within a largely virtual environment; small biotech/pharma experience preferred
  • Embraces company core values: 1. put patients first; 2. think independently, 3. be radically transparent; 4. every minute counts; and 5. let science speak

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
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Director of Regulatory Affairs

Apply Now