Job Title

IntroductionWe 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. You'll manage a talented Regulatory Affairs team and serve as the main point of contact for global health authorities (FDA, Health Canada, EMA).ResponsibilitiesShape and lead regulatory strategy for early development programsConsult with clients during pre-award phase to define regulatory needsLead regulatory content for proposals and client meetingsManage and mentor a high-performing regulatory teamServe 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 filingsPartner with internal teams across Clinical, CDMO, Medical Writing, and Project ManagementMonitor changing regulations and industry trendsImplement best practices and SOPs for compliance and efficiencyRequirementsAdvanced degree in life sciences or regulatory-related discipline (PhD preferred)10+ years of Global Regulatory Affairs experience in a CRO, biotech, or pharma environmentProven track record leading early-stage regulatory strategy and submissionsStrong knowledge of FDA and Health Canada requirements (IND, CTA)Excellent communication and cross-functional leadership skillsSound scientific and business judgmentUnderstanding of GMP, GLP, and GCP practicesWhat We OfferWhy 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 UsBrunel 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.