Associate Director/Director, Regulatory Operations

Eidos Therapeutics, a subsidiary 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 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 the US (San Francisco, Palo Alto, Boston, New York, Raleigh), and EMEA (Zug, Switzerland) with small satellites in other parts of the country. 

To learn more, visit us at  eidostx.com/ www.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

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 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.