Senior Director, Regulatory Strategy Consulting

Senior Director, Regulatory Strategy Consulting Join Halloran Consulting Group, Inc. as a Senior Director, Regulatory Strategy Consulting. Reporting to the Vice President of Regulatory Affairs, this leader will shape and drive global regulatory strategies across diverse therapeutic portfolios. You will combine deep regulatory expertise, strategic foresight, and business development acumen to deliver innovative solutions for our clients. You will lead cross-functional teams, represent clients in critical health authority engagements, and act as a trusted partner to senior leadership. The ideal candidate thrives at the intersection of strategy and execution, balancing technical mastery with consultative leadership to deliver meaningful impact for clients and the organization. Key Responsibilities Provide regulatory strategy and leadership to clients through design and implementation of global regulatory strategies across development programs; proactively identify and mitigate regulatory risks to ensure alignment with client objectives. Lead 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; partner with internal teams and external client teams/vendors to ensure quality, timely, and compliant submissions. 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 capacity planning and utilization trends to ensure project delivery across the portfolio. Coach and mentor regulatory teams; foster a culture of innovation, collaboration, and continuous professional development. Partner with Business Development leadership to foster long-term client relationships and identify expansion opportunities; participate in BD calls as SME, contribute to RFPs, bid defenses, and proposal development. Build and maintain client relationships to expand existing accounts and identify new opportunities; ensure client satisfaction with delivery quality; monitor industry trends to support growth. Drive operational excellence by embedding best practices and governance for high-quality execution; contribute to thought leadership and industry impact through content creation and events. Contribute to marketing materials and social media to showcase Hallorans expertise; support development of thought leadership materials such as whitepapers and case studies. Qualifications Required Bachelors degree in a scientific discipline with at least 15 years of Regulatory Affairs experience in biotechnology and/or pharmaceutical industries. Prior consulting or service-provider experience with a track record of managing high-profile accounts and client satisfaction. Strong leadership skills in line management, coaching, and team development; proven ability to lead cross-functional, multi-disciplinary teams and manage complex regulatory submissions. Strong business development skills with experience in winning new business and expanding accounts; ability to serve as SME in client engagements. Demonstrated strength in risk management, compliance governance, and process optimization; highly collaborative with exceptional written and verbal communication skills. Preferred Advanced degree (PhD, PharmD, MD, or MSc) and/or RAC certification. Expertise in regulatory strategy, product development, and/or regulatory CMC. Experience across multiple product types (biologics, small molecules, cell and gene therapy, oligonucleotides, peptides). Experience in CNS/neurology, metabolic, oncology, or rare diseases; recognized thought leader through conference presentations, publications, or advisory board participation. Compensation and Benefits The targeted base compensation range is between $200,000 and $260,000 annually. This range is Hallorans good-faith estimate and may be adjusted based on experience and qualifications. Benefits include annual discretionary bonus based on company and individual performance, comprehensive Medical, Dental, and Vision Insurance, 401(k) Plan, flexible PTO, and opportunities for continued learning. Additional Information Notice: Halloran does not sponsor visas for employees. All remote employees must have a consistent home internet connection with speeds of at least 25 Mbps. Halloran is an equal opportunity employer committed to diversity, equity, and inclusion. All qualified applicants will receive consideration without regard to protected characteristics. Reasonable accommodation is available upon request for applicants with disabilities. In compliance with federal law, all hires will verify identity and eligibility to work in the United States. No agencies please; no agency claims over candidates without a written agreement with Halloran signed by an authorized representative. #J-18808-Ljbffr