Senior Project Management Office Stakeholder Integration Focal
Boeing
ServiceNow
Associate Director/Director, Regulatory Project Management
BridgeBio
full-time
Posted on:
Location: California • 🇺🇸 United States
Visit company websiteSalary
💰 $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
