Note: The job is a remote job and is open to candidates in USA. Clinical Outcomes Solutions (COS) is a global research consulting group providing support and services across all facets of clinical outcomes research. The Regulatory Project Manager will design and execute comprehensive regulatory strategies for client projects, emphasizing strategic regulatory planning and cross-functional leadership.
Responsibilities
- Create and maintain project management plans by translating regulatory strategy into comprehensive, actionable plans that include detailed timelines, clear milestones, and critical paths, to enhance planning and decision-making
- Drive the execution of regulatory plans to ensure daily operations align with goals across global programs
- Identify and propose innovative regulatory pathways that meet global regulatory standards and business objectives
- Work in close collaboration with cross-functional teams and senior leadership to promote clarity, alignment, and responsibility for regulatory deliverables and timelines
- Identify any potential risks to projects and develop plans to mitigate them
- Identify and document any lessons learned and associated actions
- Facilitate meetings and other relevant project forums, ensuring meetings are structured, purposeful, and focused on decision-making and regulatory execution
- Apply best practices in project management to manage meeting tasks, including preparing and distributing agendas, defining meeting objectives, and documenting key decisions and action items
- Support effective governance, meeting cadence, and stakeholder communication across global and regional teams
- Anticipate and address complex regulatory project challenges, implementing scalable solutions to enhance team effectiveness and submission readiness
- Prepare and present strategic dashboards, reports, and scenario plans to senior stakeholders, translating regulatory progress into actionable insights
- Monitor progress of projects to ensure timely and accurate completion
- Perform research to stay up to date on regulatory changes and industry best practices
Skills
- BA/BS degree in psychology, epidemiology, educational psychology, outcomes research, sociology or related areas
- PMP Certification
- A minimum of 10 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences field, with at least 5 years in regulatory or regulatory program management
- Proven ability to partner on regulatory strategy and execute across all stages of clinical development, submissions, and global registration
- Deep technical understanding of U.S. regulatory requirements and a working knowledge of international regulations
- Success in managing complex regulatory deliverables in a matrixed organization while keeping aligned with strategic objectives
- Experience with FDA submissions and proficiency in regulatory documentation and submission strategies
- Exceptional skills in communication and influence, able to distill complex regulatory information into clear, actionable insights for senior leadership
- Strong judgment and agility in managing competing priorities and resource constraints in a dynamic environment
- Expertise in project management tools and best practices to enhance visibility and efficiency across project teams
- Demonstrated experience in facilitating cross-functional meetings and maintaining accountability within a matrixed setting
- A commitment to continuous learning and improvement, along with an innovative approach to regulatory execution
- Ability to work in a dynamic and client-focused environment
- Ability to multitask and perform multiple critical tasks simultaneously (under dynamic and ever-changing circumstances)
- Strong project management skills and experience managing research projects within a team
- Advanced technical fluency with relevant software and other resources, such as Microsoft Project, Word, Excel, and PowerPoint
- Advanced degrees (MS, PharmD, PhD) preferred
Company Overview
Company H1B Sponsorship