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
We use essential cookies to make this site work. With your permission we would also like to use the optional cookies below. Nothing optional is set until you choose, and you can change your mind at any time from "Cookie settings" at the bottom of every page. Cookie policy.
Essential — keep the site working and secure, and remember the choice you make here. Always on.