Regulatory Project Manager / Sr. Project Manager, Regulatory Affairs

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

We are seeking a detail-oriented and proactive Project Manager/Senior Manager, Regulatory Affairs, to join our pharmaceutical team. This role will involve leading and managing regulatory activities to support product development, approval, and post-marketing compliance. The ideal candidate will have a strong understanding of regulatory requirements and processes, excellent project management skills, and the ability to collaborate effectively across cross-functional teams. 

Responsibilities

• Develop, implement, and manage regulatory strategies to support global submissions, product approvals, and lifecycle management, ensuring alignment with company objectives and regulatory requirements
• Monitor and interpret global regulatory guidelines and policies to ensure company compliance
• Oversee the preparation, submission, and maintenance of regulatory filings, including INDs, NDAs, MAAs, and other regional filings
• Manage timeline preparation for CMC, Clinical, and Nonclinical Modules, ensuring successful and timely global marketing application submissions
• Track submission deliverables, manage workflows, and provide support for regulatory submissions by coordinating with team members
• Collaborate with cross-functional teams to align regulatory activities with overall project goals, providing hands-on contributions when necessary
• Lead program activities, including the creation and management of reports, dashboards, and scorecards, and conduct risk assessments to keep projects on track
• Communicate program status and escalate risks to stakeholders, ensuring smooth coordination of activities and resolution of issues with cross-functional partners
• Provide PM support for meetings and interactions with international regulatory agencies, including developing briefing packages
• Ensure effective communication and collaboration between internal teams and external consultants, aligning regulatory strategies and submission requirements with project milestones
• Provide regulatory support for internal and external audits, ensuring readiness and compliance

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

• Qualifications: 
  • Education: Bachelor’s degree in life sciences, pharmacy, or a related field
• Experience: 
  • Minimum: 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
• Knowledge: 
  • Comprehensive understanding of global regulatory requirements (FDA, EMA, ICH, etc.) and drug development processes
• Skills: 
  • Strong project management skills, with the ability to manage multiple priorities and meet deadlines
  • Excellent written and verbal communication skills
  • Proficiency in MS Office Suite and project management tools
• Competencies: 
  • Strong analytical and problem-solving skills
  • Attention to detail and commitment to quality
  • Ability to work collaboratively in a team-oriented environment
  • Leadership and mentoring abilities
  • Adaptability to a fast-paced and dynamic work environment

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