Director, Regulatory Affairs

Overview

In this role you guide clients through drug, biologic, and medical device development, leading regulatory teams and shaping strategy to deliver high-quality submissions. You’ll be the trusted HA liaison and translate complex requirements into actionable plans, acting as SME, technical lead, or consulting lead across project teams. You will review regulatory and scientific documents and drive outcomes that advance innovative therapies and global health. This position combines leadership, technical depth, and client-facing impact in a fast-paced, transformative setting.

Pay / Benefits

• Comprehensive benefits package per location
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid working depending on location
• Leadership and mentoring opportunities
• Internal growth opportunities and career progression
• Spot Bonus Award Program

Responsibilities

• Maintain advanced knowledge of HA guidance and regulations for filings across all development stages
• Review and prepare HA meeting requests and briefing documents
• Oversee and manage regulatory projects of varying complexity
• Provide strategic advice to translate regulatory requirements into practical plans
• Apply advanced CTD knowledge to regulatory submissions

Key requirements

• 8 years of regulatory experience with US FDA, Health Canada, and/or European authorities
• Advanced regulatory knowledge for US, EU, and/or Canada drug, biologic, or device development
• Proven strategic leadership in regulatory projects and cross-functional contexts

• leadership
• strategic thinking
• mentoring and team building
• CTD format knowledge
• regulatory submissions preparation and review
• HA interactions and briefing/joint-activities

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