Senior Director, Regulatory & Scientific Affairs

Senior Director, Regulatory & Scientific Affairs Job Category : Reg & Scientific Affairs Requisition Number : SENIO001708 Posted : March 9, 2026 Full-Time Remote Locations United States - Remote 100 E Rivercenter Blvd. Ste 1600 Covington, KY 41011, USA Senior Director, Regulatory Strategy & Scientific Affairs Strategic Consulting | Advanced Therapies | Global Role Shape the future of complex drug development We are seeking an experienced Senior Director, Regulatory Strategy & Scientific Affairs, to join our growing Strategic Consulting team. This is a high-impact, client-facing role for a regulatory leader who thrives at the intersection of science, strategy, and innovation and who wants to go beyond traditional regulatory execution to lead complex programs and influence critical development decisions. You will work directly with biotech and pharma clients to drive and execute regulatory strategy within active programs, particularly in high-complexity settings such as cell and gene therapy (CGT) and other advanced modalities. What you will do Lead regulatory strategy for complex programs Own and drive global regulatory strategy across: CMC (including biologics and advanced therapies) Device and combination products Provide deep scientific and regulatory leadership to guide critical program decisions Partner with clients to deliver strategic outcomes Act as a senior regulatory leader within ongoing engagements, working closely with client stakeholders Lead program-level strategic discussions, particularly in complex or high-risk scenarios Build strong relationships through delivery excellence and strategic insight, contributing to long-term partnerships Lead global health authority interactions Represent programs in interactions with FDA, EMA, MHRA, and other agencies Own the scientific and regulatory narrative presented to health authorities Lead preparation of: Briefing packages IND/CTA and IMPD strategies Key regulatory responses and negotiations Work across disciplines to deliver integrated solutions Collaborate with experts in: Clinical and Translational Strategy Medical and Safety teams Ensure alignment across CMC, nonclinical, and clinical strategy Translate complex inputs into cohesive development strategies Support consulting growth and delivery excellence Contribute to proposal development and strategic scoping of projects Identify opportunities to expand scope within active programs Mentor team members and contribute to a high-performing consulting environment What we're looking for Advanced degree (PhD, PharmD, MS) in life sciences or a related field 12+ years of experience in Regulatory Affairs, with strong focus on strategy Experience in a CRO, consulting firm, or client-facing advisory role Deep expertise in: CMC and/or nonclinical regulatory strategy Advanced therapies (e.g., cell & gene therapy, biologics) Proven success leading health authority interactions and complex programs Strong ability to translate science into regulatory strategy and decisions What sets you apart You combine scientific depth with strategic thinking You are comfortable operating in complex, high-uncertainty environments You focus on impact and decision-making, not just deliverables You communicate with clarity and confidence at both scientific and executive levels How this role fits within our consulting model Regulatory Strategy & Client Advisor – Leads client engagement, opportunity shaping, and early strategy Senior Director, Regulatory Strategy (this role) – Leads deep regulatory strategy, program execution, and health authority interactions Cross-functional experts (Clinical, Quantitative, Medical) – Integrated into a unified team to deliver end-to-end development strategy Work on cutting-edge therapies and complex development programs Be part of a high-growth, integrated consulting model Have direct impact on program success and regulatory outcomes Collaborate with a global, science-driven team focused on innovation Equal Opportunity Employer/Veterans/Disabled Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr