Regulatory Project Manager, Senior Project Manager, Regulatory Affairs

Summary

Join Calcilytix Therapeutics, a BridgeBio Pharma affiliate, as a detail-oriented and proactive Project Manager/Senior Manager, Regulatory Affairs. You will lead and manage regulatory activities supporting product development, approval, and post-marketing compliance. This role requires a strong understanding of regulatory requirements and processes, excellent project management skills, and effective cross-functional collaboration. The ideal candidate will have 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry and a Bachelor's degree in a related field. BridgeBio offers a competitive compensation and benefits package, including flexible PTO, opportunities for career advancement, and a collaborative work environment.

Requirements

• 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

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

Benefits

• 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
• 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