Associate Director/Director, Regulatory Operations

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our product candidate, AG10, is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

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 eidostx.com/ | https://bridgebio.com

Who You Are:

The Associate Director/Director of Regulatory Operations is a member of the Regulatory Affairs, and Medical Writing functions within Eidos Therapeutics and works in a hands-on capacity to support projects through new product development and commercialization. Working creatively and independently, you will support and facilitate cross-functional efforts to meeting company goals within Eidos and across BridgeBio affiliates as needed. This role is expected to establish an overall planning capability along with resourcing and leading a scalable and appropriately resourced Regulatory Operations function.

Responsibilities:

• Work closely with Regulatory Affairs, Medical Writing, and various stakeholders and project teams to provide operational oversight and support for the planning, preparation, tracking, and timely submission of all health authority applications and updates to global health authorities (e.g., IND, NDA, BLA, MAA, etc.)
• Independently manage submission projects across all submission types throughout the product lifecycle at any level of complexity
• Manage publishing activities including oversight of vendors, preparation and transfer of final documents to a third-party publishing organization, troubleshooting and supporting the third-party publisher during submission preparation, managing and completing QC of output from a third-party publisher, confirming submission to the health authority
• Responsible for communication, planning, and other activities with third-party publishing organizations
• Track regulatory commitments and deliverables to health authorities
• Provide technical support from Regulatory Affairs and Medical Writing to stakeholders, project team members, and technical/medical writers
• Provide input and guidance on current technical aspects of submission requirements such as CDISC nonclinical and clinical dataset requirements, etc. Works with internal stakeholders and vendors/CROs to update CDISC packages to meet compliance requirements
• Lead the development and implementation of standard procedures for publishing, archiving, metrics, and process for global health authority submissions
• Develop and maintain templates and style guides for regulatory submissions with inputs from Regulatory, Medical Writing, and internal stakeholders
• Maintain an index and archive of all regulatory submissions and correspondence
• Maintain and implement necessary changes to the company regulatory information management system (Veeva RIM) used for authoring and finalization of regulatory documents, preparation of submission contents and submission archive, and maintenance of correspondence and commitments; collaborate with internal stakeholders and IT to maintain or improve the connection between Veeva vault platform (e.g., PromoMats, Quality Vault, Vault Clinical)
• Monitor and assess business trends, pending regulations or guidance documents, and emerging technologies for potential regulatory operations impact, develop action plans, countries requirements guides, and business tools accordingly
• Support Regulatory budgeting and forecasting activities, including managing expenditures activities related to approved vendor contracts
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:

• A BS, or advanced degree, in life/physical sciences with 7+ years regulatory affairs or regulatory operations experience within the pharmaceutical or biotechnology industry with 3+ year's driving the regulatory and operational aspects of regulatory submissions
• Regulatory submissions experience, particularly with large applications such as NDA, BLA, MAA, etc., ideally experienced in all phases of product development, pre-and post-marketing
• Experience managing teams desired
• Experience maintaining document management systems
• A strategic as well as an operational approach with the ability to "think outside the box" and to manage multiple tasks in a fast-paced environment
• Excellent problem-solving ability and organizational skills while maintaining attention to detail. A high energy level, a willingness and ability to work in a hands-on capacity, to adapt and respond to a rapidly changing environment, and to work effectively in a project team environment
• Practical verbal and written communication skills, excellent interpersonal skills, and a team approach
• Ability to establish and maintain excellent relationships when dealing with sensitive and/or complex issues and tight timelines
• Direct experience with Veeva Vault RIM is a plus

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.