Vice President, Regulatory Affairs

Full-TimePhoenixBoston, MARegulatory Affairs

Apply Now

About Phoenix Tissue Repair & BridgeBio Pharma

Phoenix Tissue Repair, an affiliate 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 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.

To learn more about our story and company culture, visit us at phoenixtissuerepair.com | https://bridgebio.com

Location:

Any office location

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

  • 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; 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 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.
careers

Vice President, Regulatory Affairs

Full-TimePhoenixBoston, MARegulatory Affairs

Apply Now