Job Title

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 marketfaster and smarterby guiding early-stage drug programs through regulatory milestones. In this senior leadership position, youll oversee regulatory strategy and operations for early-stage drug development, with a focus on first-in-human and first-in-class molecules. Youll manage a talented Regulatory Affairs team and serve as the main point of contact for global health authorities (FDA, Health Canada, EMA). Responsibilities 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 Monitor changing regulations and industry trends Implement best practices and SOPs for compliance and efficiency Requirements 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 Strong knowledge of FDA and Health Canada requirements (IND, CTA) Excellent communication and cross-functional leadership skills Sound scientific and business judgment Understanding of GMP, GLP, and GCP practices What We Offer Why apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding. We will get you going while you get on with the job. About Us Brunel has a reputation for working with some of the best in the business. That is what we continually strive for. Over 45 years, we have created a global network of interesting clients and talented individuals working together through a vast array of services.