BridgeBio

Associate Director/Director, Regulatory Project Management

BridgeBio

full-time

Posted on:

Origin:  • 🇺🇸 United States • California

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Salary

💰 $175,000 - $240,000 per year

Job Level

Senior

Tech Stack

Spring

About the role

  • 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 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 leading or co-leading meeting series with cross-functional teams, developing and managing timelines, tracking action items, and preparing for meetings and interactions with international regulatory agencies
  • 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

Requirements

  • Bachelor’s degree in life sciences, pharmacy, or a related field
  • Minimum: 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
  • Comprehensive understanding of global regulatory requirements (FDA, EMA, ICH, etc.) and drug development processes
  • 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
  • Leadership and mentoring abilities
  • Adaptability to a fast-paced and dynamic work environment