Vice President, Regulatory Affairs

Full-TimePhoenixAny Office LocationRegulatory Affairs

Apply Now

Phoenix Tissue Repair, a subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on advancing a novel systemic treatment for recessive dystrophic epidermolysis bullosa (RDEB) a rare genetic disease affecting the skin and other organs. Our dedicated team of industry veterans is working to develop BBP-589, an investigational protein replacement therapy that uses a recombinant collagen type VII (rC7) to treat RDEB. BBP-589 represents the only potentially disease-modifying treatment in development that may solve the systemic manifestations of RDEB and the more visible skin-related aspects of this devastating disease. 

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. 

To learn more, visit us at phoenixtissuerepair.com | bridgebio.com 

Who You Are:

Phoenix Tissue Repair is hiring a Vice President, Regulatory Affairs, to lead, develop and execute global regulatory strategies aimed at the most efficient regulatory pathway for the Company's drug development program. This involves collaboration with cross-functional project teams in planning development strategies and leading global regulatory submissions for assigned projects.  The incumbent may also be responsible for supporting Company growth and infrastructure activities and execute on strategies developed.
Responsibilities:
  • Serve as the key regulatory team member with responsibility for regulatory strategies and execution of submissions for assigned projects
  • Provide regulatory guidance and strategy for support of product development and registration strategies, including broad regulatory oversight for program development
  • Ensure high-quality and timely regulatory submissions (IDE/PMA as well as IND/CTA/NDA/BLA/MAA, as applicable) in compliance with all applicable regulatory requirements and alignment with corporate goals
  • Act as the primary liaison between the Company and regulatory authorities
  • Direct and assist internal staff and regulatory consultants, as required, to ensure compliance of the Company's drug development activities with all U.S. and international requirements
  • Perform all duties in keeping with the Company's core values, policies, and all applicable regulations
Education, Experience & Skills Requirements:
  • BA/BS degree in the biological or physical sciences; advanced degree preferred
  • Industry-related regulatory experience in Pharmaceuticals, Biopharmaceuticals or Biotechnology industry, large and small 
  • Ten years minimum industry experience is generally required
  • Knowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and industry-standard practices
  • Proven ability to think strategically 
  • 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
  • Great attention to detail; ability to organize, prioritize, and delegate
  • Experience interacting with CROs in the management of U.S. eCTD IND submissions and ex-US CTAs towards clinical trial activations preferred
  • Proficient user of standard M.S. Office suite (e.g., Word, Excel), experience using electronic document management systems and document review tools
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
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
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Vice President, Regulatory Affairs

Full-TimePhoenixAny Office LocationRegulatory Affairs

Apply Now