Director/Sr. Director, Regulatory Affairs - CMC

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a commercial 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. Attruby (acoramdis) is an orally administered small molecule designed to stabilize TTR, a 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, 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 eidostx.com/ | https://bridgebio.com

Who You Are

This experienced Regulatory Affairs team member will provide CMC regulatory expertise and support for development project work, including oversight of CMC regulatory submissions working closely with CMC QA and regulatory stakeholders. This individual will represent CMC Regulatory Affairs on CMC and Regulatory sub-teams with respect to RA CMC deliverables for Rest of World (ROW) filing, including as required, Submission and Change Control teams. This individual will ensure the planning, development, and finalization of high-quality CMC documentation designed to meet regulatory requirements while overseeing US post-approval submissions and ex-US global registrations as applicable. 

This individual is the responsible subject-matter expert in the field of Regulatory CMC with experience filing a successful NDA/MAA for a new chemical entity and will function as an individual contributor and have a direct influence on the decision-making processes within the scope of CMC-related activities across BridgeBio Cardiorenal affiliates (Eidos and Calcilytix) as needed. 

The successful candidate is expected to develop strong relationships with various departments and different management levels, including interactions across BridgeBio affiliates. The scope ranges from early clinical development through submission and maintenance of license applications. 

Responsibilities

• Work closely with CMC and Quality colleagues to develop CMC regulatory submission strategies for ROW and other regions as necessary, complete content review, assure compliance with regulatory standards and health authority guidance while maintaining submission timelines to meet business objectives 
  • Plan and track the completion of CMC content for NDA/MAA and IND/CTA submissions while ensuring company template content conforms with regulatory requirements 
  • Coordinate responses to CMC information requests from health authorities 
  • Ensure that appropriate documented quality control (QC) checks are performed for CMC documents before health authority submission and respond to findings, and recommend process improvements as needed 
• Collaborate with CMC Team and Quality to ensure regulatory conformance of technical documentation, including technical transfer protocols, validation protocols, and technical reports, manufacturing and packaging/labeling information 
• Ensure communication and alignment on CMC regulatory strategy through partnership and communication with internal key stakeholders 
• Proactively identify potential risks to programs and contribute to solutions to keep assigned programs on track while maintaining high-quality 
• Ensure that CMC-related changes are reported to authorities per regulatory requirements 
  • Responsible for regulatory impact assessments for CMC change control 
• Lead preparation for health authority meetings with CMC focus and participate in multidisciplinary efforts to prepare CMC updates to regulatory documents including, Investigator Brochures, Annual Reports, and briefing documents for health authority meetings 
• Work closely with the regulatory operations group to ensure proper archival of CMC-related Health Authority correspondence, regulatory commitments and Agency reporting obligations for the organization 
• Maintain knowledge of current and emerging CMC regulatory requirements, guidelines, and best practices, and effectively communicate relevant topics to colleagues 
• Oversee responsibilities for department staff and vendors as agreed with the manager 
• Support other Regulatory Affairs functions as needed 

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

• BA/BS degree in chemistry or similar required, post-graduate degree preferred 
• Successful experience leading Regulatory CMC activities for multiple regulatory filings in pre-and post-approval settings, including experience filing an NDA/MAA for an NCE 
• Excellent oral and written communication skills with proven ability to analyze and organize information logically 
• Thorough knowledge of drug development, health authority regulations and guidelines, CMC and Quality documentation standards, with the ability to apply knowledge to guide the delivery of regulatory documents efficiently 
• Strong leadership and project management skills, ability to work independently, multi-task, and work effectively under pressure 
• Excellent interpersonal, active listening, and influencing skills 
• Strong collaboration, teamwork, organizational skills, and attention to detail 
• Prior management experience preferred 

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