Senior Director Regulatory Affairs - PhD Job at Brunel, Canada

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  • Brunel
  • Canada

Job Description

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.

Job Tags

Full time, Internship,

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