Manager/Senior Manager, Regulatory Affairs

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Job description

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate 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 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, Boston, New York, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at eidostx.com/ |

Who You Are:

The candidate will have demonstrated the ability to work independently or with limited oversight. Furthermore, the candidate will have demonstrated knowledge of regulatory requirements and guidelines and apply their knowledge to daily work while managing critical projects as part of an interdisciplinary team.

Responsibilities:

• Independently or with limited oversight plan, compile, review, and submit documents for the company, including but not limited to initial INDs/CTAs/NDAs and amendments or supplements
• Assist regulatory management and project teams in the development and implementation of regulatory strategies and plans
• Develop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of regulatory documentation
• Participate in the review of critical documents such as protocols, ICFs, IBs, CSRs, DSURs, etc., to ensure they are compliant with relevant regulations and guidance (e.g., ICH, FDA, EMA, etc.) before submission
• Coordinate with vendors to appropriately plan and finalize submissions to health authorities per regulations and guidelines
• Contribute to the maintenance of regulatory databases, including submissions and correspondence logs
• Independently plan daily work to complete time-sensitive assignments
• Review, write, and present guidelines and SOPs as needed to support high-quality submissions and assure adherence to regulatory requirements
• Maintain current knowledge of the applicable US and global regulations, guidance, and standards for drug development and product registration
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 towards 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 minimum of a Bachelors Degree required (life sciences disciplines strongly preferred) with approximately five years of experience in the biotechnology or pharmaceutical industries in regulatory affairs or related functions in drug/biologics development/manufacturing (an equivalent combination of education and experience may be considered)
• Great attention to detail, ability to work on multiple projects with tight deadlines, and able to work independently
• Demonstrated experience working to support eCTD formatted submissions for drugs and/or, e.g., INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements
• e.g., Has successfully coordinated or supported responses to health authorities or other critical submission projects while maintaining agreed timelines
• Previous experience with NDA or BLA submissions is desirable
• Experience in managing all components of regulatory submissions (including chemistry, manufacturing, and controls) is a plus
• Understanding of the drug development process, FDA/EMA guidance and regulations, and knowledge of global guidance
• Demonstrate a creative approach to problem-solving; with a demonstrated track record of being results-driven
• Excellent oral and written communication skills and time management skills essential
• Demonstrated ability to work effectively with and/or lead cross-functional team activities e.g., research, clinical, and CMC teams
• Ability to develop regulatory plans and strategies while proactively identifying risks
• Ability to work on multiple tasks to meet company objectives
• Strong attention to detail
• Knowledge of 21 CFR and FDA, ICH, GCP, GMP, and global guidelines
• Excellent Computer Skills - MS Word, Excel, PowerPoint, and document management software/system

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 - with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.