Associate Director/Director, Regulatory Project Management

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 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