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 mul