Senior Director, Regulatory Strategy Consulting

Senior Director, Regulatory Strategy Consulting

4 days ago – Be among the first 25 applicants

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

Base pay range

$200,000.00/yr - $250,000.00/yr

Position Overview

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.

Roles and Responsibilities

Regulatory Strategic Leadership

• 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.

Billable Utilization Target

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

Team Leadership and Talent Development

• 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.

Business Development and Account Growth

• 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.

Operational Excellence and Process Improvement

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

Thought Leadership and Industry Impact

• Contribute to thought leadership rainmaking activities to influence and provide perspectives to our industry and clients.
• Generate content (whitepapers, case studies) to showcase expertise and shape industry perspectives.
• Provide presence at industry events, conferences and forums.
• Support the development of marketing materials and social media posts that showcase Halloran’s expertise and breadth of expertise.

Other related duties and projects as required and assigned.

Required

• Bachelor’s degree in scientific discipline with at least 15 years of Regulatory Affairs experience in the biotechnology and/or pharmaceutical industry.
• Prior consulting or service provider experience and a demonstrated ability in managing high-profile accounts and fostering client satisfaction.
• Strong leadership skills in line management, coaching, and team development.
• Proven track record leading cross‑functional, multi-disciplinary teams and managing complex, high-profile regulatory submissions.
• Strong business development skills with experience in winning new business, expanding accounts, and serving as SME in client engagements.
• Demonstrated strength in risk management, compliance governance, and process optimization.
• Highly collaborative, with exceptional written, verbal, and interpersonal communication skills.

Preferred

• Advanced degree (PhD, PharmD, MD, or MSc) and/or RAC certification.
• Expertise within regulatory strategy, product development, and/or regulatory CMC.
• Experience across multiple product types (e.g., biologics (proteins, mABs, ADCs), small molecules, cell and gene therapy, oligonucleotides, peptides).
• Experience in central nervous system (neurology / psychology), metabolic, oncology, or rare diseases.
• Recognized thought leader through conference presentations, publications, or advisory board participation.

Seniority level

• Director

Employment type

• Full‑time

Job function

• Legal

Industries

• Pharmaceutical Manufacturing

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