Senior Director Regulatory Affairs - calgary

Job Description

<p><b>Introduction</b></p><p>We are currently hiring a <b>Senior Director, Drug Development & Regulatory Strategy </b>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.</p><p>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).</p><p><br></p><p><b>Responsibilities</b></p><ul><li>Shape and lead regulatory strategy for early development programs</li><li>Consult with clients during pre-award phase to define regulatory needs</li><li>Lead regulatory content for proposals and client meetings</li><li>Manage and mentor a high-performing regulatory team</li><li>Serve as main liaison with regulatory agencies (FDA, Health Canada, EMA)</li><li>Guide preparation for regulatory meetings (e.g. pre-IND, pre-CTA)</li><li>Oversee submission content for INDs, CTAs, and other filings</li><li>Partner with internal teams across Clinical, CDMO, Medical Writing, and Project Management</li><li>Monitor changing regulations and industry trends</li><li>Implement best practices and SOPs for compliance and efficiency</li></ul><p><br></p><p><b>Requirements</b></p><ul><li>Advanced degree in life sciences or regulatory-related discipline (PhD preferred)</li><li>10+ years of Global Regulatory Affairs experience in a CRO, biotech, or pharma environment</li><li>Proven track record leading early-stage regulatory strategy and submissions</li><li>Strong knowledge of FDA and Health Canada requirements (IND, CTA)</li><li>Excellent communication and cross-functional leadership skills</li><li>Sound scientific and business judgment</li><li>Understanding of GMP, GLP, and GCP practices</li></ul><p><br></p><p><b>What We Offer</b></p><p>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.</p><p><br></p><p><b>About Us</b></p><p>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.</p>