Senior Director / Director

Introduction We are currently hiring a Senior Director, Drug Development & Regulatory Strategy for our client, a growing, mission-driven organization in the drug development space.

This company focuses on helping bring new therapies to market—faster and smarter—by guiding early-stage drug programs through regulatory milestones.

In this senior leadership position, you’ll oversee regulatory strategy and operations for early-stage drug development, with a focus on first-in-human and first-in-class molecules.

You'll manage a talented Regulatory Affairs team and serve as the main point of contact for global health authorities (FDA, Health Canada, EMA). Shape and lead regulatory strategy for early development programs Consult with clients during pre-award phase to define regulatory needs Lead regulatory content for proposals and client meetings Manage and mentor a high-performing regulatory team Serve as main liaison with regulatory agencies (FDA, Health Canada, EMA) Guide preparation for regulatory meetings (e.g.

pre-IND, pre-CTA) Oversee submission content for INDs, CTAs, and other filings Partner with internal teams across Clinical, CDMO, Medical Writing, and Project Management Implement best practices and SOPs for compliance and efficiency Advanced degree in life sciences or regulatory-related discipline (PhD preferred) ~10+ years of Global Regulatory Affairs experience in a CRO, biotech, or pharma environment ~ Proven track record leading early-stage regulatory strategy and submissions ~ Sound scientific and business judgment ~ Finding the next step in your career can be a full-time job in itself.

Over 45 years, we have created a global network of interesting clients and talented individuals working together through a vast array of services.