Sr. Director, Regulatory Operations, Business Systems

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 20+ 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, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, 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 Sr. Director of Regulatory Operations, Business Systems is a member of the Regulatory Operations expanded team within BridgeBio 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 meet the company goals within BridgeBio and across BridgeBio affiliates as needed. This role is expected to lead, strengthen, and expand the established Veeva RIM infrastructure as the Business Administrator, in coordination with other Veeva Vault counterparts and IT.

Responsibilities

• Lead Veeva RIM activities and oversight, and maintain Veeva RIM as Business Administrator
• Support the Regulatory Operations team to implement necessary changes in Veeva RIM to ensure continuity of submission content management, submission archive, and Health Authority interactions
• Collaborate with internal stakeholders and IT to maintain and/or improve Veeva RIM within the broader platform (e.g., Quality, Clinical, etc.)
• Serve as the business sponsor for affiliate onboarding into Veeva RIM
• Support the affiliate on-boarding and training with oversight of the program and address technical challenges in the migration to Veeva RIM and apply lessons learnt to future transitions
• Provide technical support to stakeholders and project team members as needed
• Provide input and/or guidance on current technical aspects of submission requirements, working with internal stakeholders and vendors/CROs to ensure submission compliance requirements are met
• Work closely with Regulatory Affairs, Medical Writing, and project teams to provide operational oversight and support for the planning, preparation, tracking, and timely submission of health authority applications and updates to global health authorities (e.g., IND, NDA, BLA, MAA, etc.) leveraging Veeva RIM
• Manage submission projects across assigned submission types throughout the product lifecycle at any level of complexity
• Ensure standard procedures for publishing, submission, archiving, metric tracking are maintained, and followed
• 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

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 toward 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 10+ years regulatory operations experience within the pharmaceutical or biotechnology industry with at least 3+ year's driving the regulatory and operational aspects of regulatory submissions and systems
• Direct experience maintaining document management systems and experience with Veeva RIM is essential, including leading enhancements and additional functionality
• 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

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