Associate Director – Regulatory Affairs

Overview

In this remote, contract-based role you lead global regulatory strategy and submissions for oncology development programs. You will serve as Global Regulatory Lead, guiding cross-functional teams and aligning with corporate objectives. You’ll identify regulatory risks, mitigate them, and steer interactions with health authorities to support development decisions. This is a high-impact position that shapes regulatory strategy and accelerates access to innovative cancer therapies.

Responsibilities

• Act as Global Regulatory Lead for development programs across the portfolio
• Develop, maintain, and execute program-level regulatory strategies aligned with development stage
• Identify regulatory risks and design mitigation plans across clinical, nonclinical, and CMC plans
• Lead cross-functional planning of regulatory submissions and lifecycle activities (annual reports, etc)
• Ensure regulatory alignment across clinical, nonclinical, and CMC components and internal teams
• Plan and prepare regulatory interactions, craft questions, meeting objectives, and positioning for health authority engagement
• Manage submissions, agency correspondence, and follow-up related to designations
• Incorporate health authority feedback into regulatory/development strategy and coordinate responses
• Author and lead preparation of regulatory designation applications (e.g., Orphan Drug, Fast Track)

Key requirements

• Bachelor’s degree in life sciences or related discipline
• 10+ years in biotechnology or pharmaceutical development with Regulatory Affairs experience
• Experience leading or supporting regulatory strategy, submissions, and health authority interactions for clinical development
• EMA and CTIS experience preferred
• Radiopharmaceuticals experience preferred
• Strong scientific/medical writing skills for regulatory narratives
• Ability to work independently in a fast-paced clinical development environment
• Experience with cross-functional collaboration across clinical, nonclinical, and CMC teams

• cross-functional collaboration
• strong scientific/medical writing
• independence and initiative
• regulatory strategy and submissions
• health authority engagement
• regulatory designations (Orphan, Fast Track)

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