Senior Director, Regulatory Strategy Consulting

Senior Director, Regulatory Strategy Consulting

4 days ago – Be among the first 25 applicants

This range is provided by Product Life Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

Reporting to the Vice President, Regulatory Affairs, the Senior Director Regulatory Strategy Consulting will serve as a primary architect of global regulatory strategies for clients across multiple therapeutic portfolios. This role combines deep regulatory expertise with strategic foresight, operational leadership, and business development acumen. The Senior Director will provide innovative strategic development solutions towards clients, represent clients in high‑stakes health authority engagements, lead cross‑functional teams and serve as a strategic partner to the Vice President of Regulatory Affairs.

Success in this role requires balancing strategic thinking, technical mastery, and consultative influence to drive organizational and client impact at scale.

Work Location:

Remote position. Travel may be required to support client deliverables, company events, and industry events & conferences.

• Provide regulatory strategy and leadership to our clients through design and implementation of global regulatory strategies across development programs, proactively identify and mitigate regulatory risks to ensure alignment with client business objectives.
• Lead the planning of major global regulatory submissions (INDs, CTAs, NDAs, BLAs) and responses, represent the client in meetings with FDA and global health authorities, lead rehearsals, moderate live health authority meetings and partner with internal teams and external client teams / vendors to ensure quality, timely, and compliant regulatory submissions and deliverables.
• Drive delivery team accountability for regulatory milestones and timelines; escape and resolve critical path issues.

• Meet a target billable utilization of 50% while driving client satisfaction and delivery excellence.

• Provide line management and performance management to inform optimal resource planning and oversee billable utilization tracking for direct reports.
• Support team capacity planning and utilization trending to ensure optimal resourcing and project delivery across the portfolio of projects.
• Coach and mentor and guide regulatory teams, to demonstrate the tools, skills, and resources needed to perform their job responsibilities. Foster a culture of innovation, collaboration, and continuous professional development.

• Partner with Business Development leadership to foster the continuation and of strong, long‑term relationships with clients and identify expansion opportunities for Halloran services. This includes participation in BD calls as the subject matter expert (SME), contributing and participating in generating a Response For Proposal (RFP), proposal development, BID defense meeting(s), as the SME.
• Build and maintain strong relationships with clients to expand existing client relationships and identify new opportunities through consultative expertise and industry engagement. This will involve working closely with clients to understand their needs, leveraging the collective team to develop product‑specific strategies and solutions that meet client needs.
• Ensuring that clients are satisfied with the quality of our delivery product.
• Understanding of industry trends and dynamics and the competitive marketplace to support business growth initiatives.
• Identify new business and expand active accounts through networking, industry events, maintenance of client relationships and professional associations.

• Drive efficiencies across regulatory consulting processes, embedding best practices and governance mechanisms for consistent, high‑quality execution.

• Contribute to thought leadership rainmaking activities to influence and provide perspectives to our industry and clients.
• Ge…