What are the responsibilities and job description for the DIRECTOR/SR. DIRECTOR, REGULATORY AFFAIRS position at BridgeBio Pharma?
About Calcilytix & BridgeBio Pharma
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 evaluated in a Phase 3 clinical 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.
To learn more about our story and company culture, visit us at https : / / calcilytix.com / | https : / / bridgebio.com
Who You Are
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 :
Education, Experience & Skills Requirements
Special Skills / Knowledge :
What We Offer
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. Below is the anticipated salary range for candidates for this role who will work in California. 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, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary
225,000-$315,000 USD
Salary : $225,000 - $315,000
