Director/Sr. Director, Regulatory Affairs

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement…read on

In 2015, we pioneered a “Moneyball for biotech” approach, pooling projects and promising early-stage research from academia under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare diseases and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 

Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

Calcilytix Therapeutics, an affiliate within BridgeBio Pharma, is developing encaleret, 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 Designation from the US FDA, EMA, and PMDA as well as Fast Track Designation from the US FDA. Results from the Phase 2b clinical study of encaleret in patients in ADH1 were published in the New England Journal of Medicine.

What You’ll Do

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

Who You Are

• 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

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities