Manager/Sr. Manager, Regulatory Publishing & Operations

About BridgeBio Pharma

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, 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

Reporting to the Head of Regulatory Publishing and Operations at BridgeBio Services, the Senior Manager will support the day-to-day activities of assigned projects' regulatory operations. These include preparing and compiling submissions for regulatory agencies, assigned clinical studies, managing regulatory submission processes and timelines, and regulatory tracking tools, archives, and infrastructure, as assigned.

Responsibilities

• Lead US FDA and select EU submission projects in conjunction with Regulatory Affairs teams at affiliates
• Manage submission preparation, transmission, and archival, ensuring adherence to internal processes and regional standards
• Manage and perform submission publishing to meet deadlines and high-quality standards (e.g., SPL, eCTD)
• Advise on regional and technical requirements for submission documents
• Provide subject matter expertise for the formatting and management of submission documents
• Provide Authoring Template and Reference Manager Software User training
• Contribute to process improvement initiatives
• Assist with other regulatory activities and special projects as needed
• Serve as an administrator to Electronic Document Management System (Veeva RIM):
• Manage users and application of Dynamic Access Control
• Manage loader and bulk actions
• Manage Submissions Content Planning
• Manage Submissions Archive
• Participate in Managed Service Check-in/Impact Assessment of new releases
• Manage Health Authority Questions/Correspondences/Commitments in collaboration with RA content owners

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

• Bachelor's degree in a life science or relevant discipline required
• 3+ years of in-depth regulatory operations experience in pharmaceutical and/or biotech product development
• 4+ years of pharmaceutical or biotech industry experience
• Recent experience (within 2 years) successfully managing the creation and submission of regulatory documents accepted on technical grounds at first pass
• Experience with regulatory submissions and formatting and tools/systems, including documents required by INDs, NDAs, CTAs, and MAAs, supplements, and briefing documents
• Electronic Document Management Systems (Veeva RIM)
• Endnote
• Knowledge and utilization of submission requirements and guidance
• Working knowledge of ICH, FDA, and EMA submission guidelines plus 21 CFR Part 312 and 314
• Strong experience with 21 CFR Part 11, 210, and 211
• Detail-oriented, organized, and committed to quality and consistency
• Deadline-driven, capable of managing competing high-priority assignments
• Excellent written and verbal communication skills
• Excellent team interaction skills and ability to work successfully in cross-functional teams
• Ability to work in a dynamic environment with a high degree of flexibility

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