Senior Director Regulatory, UK & Access Consortia

Full-TimeBridgeBio InternationalUnited KingdomRegulatory Affairs

Apply Now

About BridgeBio

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 aim 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://bridgebio.com

Who You Are:

The Senior Director would be the regional lead (EU RAD) for the company lead investigational product Acoramidis for ATTR-CM and ATTR-PN. They will lead and build the regional team, with strong links to the Market Access, Patient Safety, and QA team, to develop and implement the regional regulatory strategy. They will work with the Global Regulatory Lead based in the US to identify and propose mitigations for the regulatory risks for the region. This individual will serve as a regional regulatory representative, with active involvement in reviewing and authoring regulatory submission content to support the worldwide submissions as efficiently as possible. The role will also be responsible for advising the BridgeBio Affiliates (Discovery and Clinical Development companies) on regulatory strategy in early development.

The Senior Director will report to the Head of Regulatory Affairs.
Responsibilities:
  • Liaise primarily with clinical, CMC, Commercial, Medical Affairs, Quality, and Regulatory Affairs members to develop and execute European Regulatory strategies aligned with business objectives
  • Provide guidance, direction, and leadership on those strategies to development teams and executive management
  • Represent European Regulatory Affairs in cross-functional development teams for assigned products
  • Build a regulatory team to support current and future portfolios
  • Provide strategic input to planned commercial campaigns to meet business objectives while ensuring regulatory compliance
  • A key contributor to the strategic roadmap for the Regulatory Affairs function
  • Ensure regulatory plans, in terms of standards, processes, and performance, are robust through identification and assessment of potential program risks
  • Serve as the primary liaison between BridgeBio Affiliates and non-US regulatory authorities to coordinate and prepare teams for meetings with regulatory authorities
  • Ensure that regulatory strategies support market access
  • Work with appropriate partners to establish, update, and implement European Regulatory policies, standards, and procedures for the company
  • Maintain up-to-date working knowledge of laws, regulations, and guidelines across European regulatory authorities
  • Participate in the review and approval of essential documents, presentations, and reports

  • 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:
  • University Degree in Science or related discipline. A higher degree would be desirable, especially one specific to regulatory affairs
  • Extensive knowledge and experience of working in one or more areas in regulatory affairs in the pharmaceutical industry or experience with a health authority for 10-15 years
  • Ideally, a combined mix of a large company and small biotech
  • Demonstrated leadership competencies in establishing clear direction and objectives; ability to simplify complex processes and foster an environment that brings out the best in people
  • Pre-and post-product launch experience in key European markets
  • Advanced knowledge and experience in interpretation of regulations, guidelines, and precedents related to drug development
  • Track record for having adopted innovative regulatory strategies for novel molecular entities
  • Strong strategic and analytical abilities
  • Electronic submission experience
  • Excellent verbal and written communication skills
  • Ability to provide solid regulatory leadership to cross-functional teams and executive management
  • Excellent team-building, leadership, and management skills
  • Excellent listening, communication, and interpersonal skills
  • Demonstrated skills in managing direct reports, vendors, and others involved in Regulatory Affairs activities to meet corporate objectives
  • Experience in mentoring staff to develop their skills and ensure they remain challenged professionally
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)
  • 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

  • #LI-Remote
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
careers

Senior Director Regulatory, UK & Access Consortia

Full-TimeBridgeBio InternationalUnited KingdomRegulatory Affairs

Apply Now