Senior Director/VP, Regulatory Affairs

Full-TimeCoASan Francisco, CARegulatory Affairs

Apply Now

About CoA & BridgeBio Pharma

CoA Therapeutics, an affiliate of BridgeBio Pharma, is developing BBP-671, a small molecule allosteric modulator of an enzyme family known as the pantothenate kinases that control coenzyme A synthesis. This therapeutic approach may have utility in diseases associated with coenzyme A depletion, including a rare neurological condition PKAN and inborn errors of metabolism such as organic acidemias.

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 https://coatherapeutics.com | https://bridgebio.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 a rare disease drug. This role involves collaboration with cross-functional project teams in planning development strategies and leading global regulatory submissions for BBP-671 in the prioritized indications of PKAN and organic acidemia.
Responsibilities:
  • Develop the global regulatory strategic roadmap for BBP-671 across PKAN and organic acidemia indications, including EMA scientific advice and PIP; ODDs and RPDDs; Pivotal planning
  • Liaise primarily with clinical, Nonclinical, CMC, Quality, and patient advocacy members to develop and execute Regulatory strategies aligned with business objectives. Provide guidance, direction, and leadership on those strategies to development teams and executive management.
  • Represent Regulatory Affairs in cross-functional development teams
  • Serve as the primary liaison and prepare teams for meetings with regulatory authorities
  • Participate in the review and approval of essential documents, presentations, and reports
  • Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep the Company informed on any relevant changes in the regulatory landscape
  • Manage, direct and assist internal staff and regulatory consultants, as required, to ensure compliance of 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 required in biological/physical sciences.  Advanced degree preferred
  • Relevant regulatory leadership experience in the biopharmaceutical industry with demonstrated capability as a successful senior regulatory leader; Minimum requirements are flexible, but ten years of minimum industry experience is generally required
  • Advanced knowledge and experience of US FDA, EMA, and international pharmaceutical guidances, regulations, drug development process, and industry-standard practices
  • Experience in rare diseases and pediatric drug development required
  • Track record for having adopted innovative regulatory strategies for novel molecular entities
  • Proven ability to think strategically
  • Proficient in written, oral, and interpersonal communications
  • Ability to manage complexity and uncertainty
  • Ability to work in a small/mid-sized company within a largely virtual environment; small biotech/pharma experience preferred
  • Experience working on programs with co-development partners
  • Embraces company core values:  1. put patients first; 2. think independently, 3. be radically transparent; 4. every minute counts; and 5. let the science speak
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.
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Senior Director/VP, Regulatory Affairs

Full-TimeCoASan Francisco, CARegulatory Affairs

Apply Now