Director/Sr. Director, Regulatory Affairs Job at BridgeBio
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 investigational product, acoramidis (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/ | https://bridgebio.com
Who You Are
This experienced regulatory professional develops and implements regulatory strategies for internal development programs. In addition, the individual implements and manages internal regulatory processes, prepares documents for regulatory submissions in compliance with global health authority regulations, and interacts with and manages relationships with health authorities and external vendors.
Responsibilities
- Responsible for managing operational activities of regulatory affairs with support from vendors
- Provide strategic direction to cross-functional teams to enable the execution of company regulatory goals while providing direct regulatory input to clinical and nonclinical activities
- Independently plan, compile, review, and submit documents for the company, including but not limited to initial INDs/CTAs/NDAs and amendments or supplements.
- Develop, maintain, and communicate timelines for regulatory submissions to ensure the timely delivery of regulatory documentation
- Participate in the review and approval process of critical documents such as protocols, ICFs, IBs, CSRs, DSURs, etc., to ensure they comply with relevant regulations and guidance (e.g., ICH, FDA, EMA, etc.) before submission.
- Manage vendors to appropriately plan and finalize submissions to health authorities in accordance with regulations and guidelines
- Ensure maintenance of regulatory databases, including submission and correspondence logs
- Review, write, and present guidelines and SOPs as needed to support high-quality submissions and assure adherence to regulatory requirements.
- Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration
- Support growth and development of the company as needed, e.g., regulatory review of external materials such as publications, corporate activities, investor relations, and other public disclosures
- 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
No matter your role at BridgeBio, successful team members are:
Education, Experience & Skills Requirements
- Degree in a relevant scientific discipline
- 10+ years of relevant experience in the pharmaceutical/biotechnology industry
- Prior leadership and/or management experience
- Successful demonstration of independent leadership related to writing and submission of regulatory filings and managing interactions with health authorities
- Demonstrated understanding of the global pharmaceutical drug development and regulatory environment
- Expert knowledge of GxP/ICH requirements as related to nonclinical, clinical, and CMC activities
- Successful experience in the preparation, submission, and approval of INDs/CTAs or NDAs/MMA
- Experience managing external vendors
- Excellent written and verbal communication skills
- Strategic thinker and planner with excellent organizational skills
- Self-motivated and goal-oriented with a proven ability to work collaboratively
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
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. The anticipated salary range for candidates for this role who will work in California is
$204,000 to $304,500/year. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
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