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 together 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 disease, 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
Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
What You'll Do
We are seeking a detail-oriented and proactive Associate Director/Director, Regulatory Project Manager, to join our 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, as well as 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
Prior experience leveraging prior MAA dossiers to create a global dossier (M2-M5) to support subsequent rest of world MAA submissions is a plus
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 creating and managing 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 Overall PM support, including:
Lead or co-lead specific meeting series with x-functional team(s) to achieve company/department goals, including developing and managing timelines, tracking action items, etc
Lead or co-lead cross-functional teams preparing for meetings and interactions with international regulatory agencies, including contributing to developing briefing packages
Influence and contribute to the vetting and interrogation of various regulatory options in pursuit of a robust regulatory strategy, and be able to clearly summarize to staff and/or executive decision makers on said strategies
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
Where You'll Work
This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco, CA office.
Who You Are
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, SmartSheet, and other project management tools
Experience creating, developing, managing, and maintaining project timelines
Skilled in task tracking, resource allocation, and reporting using project management software
Ability to optimize collaboration and efficiency through 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
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
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.