ProductLife Group · 1 day ago
Senior Director, Regulatory Strategy Consulting
United States
Full-time
Remote
Director/Executive
$200K/yr - $250K/yr
15+ years expProductLife Group is seeking a Senior Director of Regulatory Strategy Consulting to architect global regulatory strategies for clients across multiple therapeutic portfolios. This role requires deep regulatory expertise combined with strategic foresight and operational leadership to drive client impact and ensure compliance with regulatory requirements.
Document ManagementInformation ServicesProduct Management
Responsibilities
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, and 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; escalate 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
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
Qualification
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
Company
ProductLife Group
ProductLife Group is a trusted partner that helps clients stay ahead of the changing R&D landscape.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Oakley Capital
2024-05-28Private Equity
2019-01-22Acquired
Recent News
2025-12-11
Precedence Research
2025-10-31
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