Director/Sr. Director, Regulatory Affairs
Calcilytix San Francisco, CA/Hybrid Regulatory Affairs
Calcilytix Therapeutics, an affiliate of BridgeBio Pharma, is developing encaleret (CLTX-305), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1), a genetic cause of hypoparathyroidism. Encaleret is currently being evaluatedinaPhase 3clinical study and has received Orphan Drug and Fast Track Designations from the US FDA.
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.
This experienced regulatory professional will have demonstrated the ability to work independently or with limited direction and oversight. The individual will manage internal regulatory processes, prepare documents for regulatory submissions in compliance with global health authority regulations, and may interact with health authorities. In conjunction with regulatory affairs leadership, they will develop strong relationships, collaborate, and interact with various departments and levels of management, including interactions across BridgeBio subsidiaries. Furthermore, the successful candidate will have demonstrated knowledge of regulatory requirements and guidelines, the ability to apply their knowledge to daily work, and the ability to represent regulatory affairs as part of an interdisciplinary team.
Responsibilities
The primary responsibilities for this position include planning, coordination, review, and assembly of regulatory documentation for submission to health authorities (e.g., FDA and global regulatory agencies). The primary job functions include, but are not limited to, the following:
- Planning, coordination, review, and assembly of regulatory documentation for submission to health authorities (e.g., FDA, EMA, and other global regulatory agencies)
- Independently or with limited oversight, plan, compile, review, and submit documents for the company, including but not limited to initial INDs/CTAs/NDAs/MAAs and amendments or supplements
- Provide regulatory direction to project teams in developing and implementing 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.) prior to submission
- Coordinate with vendors to appropriately plan and finalize submissions to health authorities in accordance with regulations and guidelines
- Maintain regulatory databases, including submission 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 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 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
- A minimum of a bachelor’s degree is required (life sciences disciplines strongly preferred) with approximately 8 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 ability to work independently.
- Demonstrated experience leading eCTD formatted submissions, e.g., INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements for drugs and/or biologics.
- Has successfully led responses to health authorities or other critical submissions while maintaining agreed timelines
- Ability to communicate regulatory expectations pertaining to the drug development process, FDA/EMA/global guidance and regulations, to cross-functional teams
Special Skills / Knowledge:
- Excellent oral and written communication and time management skills are essential
- Demonstrated ability to work effectively with and/or lead cross-functional team activities, e.g., research, clinical, and CMC team
- Ability to develop regulatory plans and strategies while proactively identifying risks
- Ability to work on multiple tasks with strong attention to detail to meet company objectives
- Knowledge of ICH, GCP, GMP, and other relevant global guidelines
- Excellent computer skills, e.g., MS Word, Excel, PowerPoint, and electronic document management software/systems
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 thishere
- 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
- Commitment to Diversity, Equity & Inclusion
#J-18808-Ljbffr
