Senior Director Regulatory Affairs

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).

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.

Compétences idéales

• GCP

• Canada

Expérience professionnelle

• Administrative

Compétences linguistiques

• English