Legend Biotech is seeking a Senior Manager, Regulatory Strategy as part of the Regulatory Affairs team based in Somerset, NJ.

Role Overview

The Senior Manager, Regulatory Strategy will report to the Director of Regulatory Affairs  and provide support and potentially function as the RA lead of a project in defining and executing global regulatory strategies across the development lifecycle, from early development through registration and lifecycle management. This individual will serve as a strategic regulatory partner to cross-functional teams and help prepare, review and manage regulatory submissions.

Key Responsibilities

• Lead the preparation, submission, management and maintenance global regulatory submissions including IND / CTAs, amendments, information requests, Orphan Drug Applications, DSUR / IB, and Marketing Applications etc.
• Coordinate and prepare for Agency meetings and meeting package preparation.
• Provide strategic regulatory input on clinical development plans, CMC strategies, and nonclinical programs to support regulatory milestones.
• Contribute to regulatory intelligence and interpretation of evolving global regulatory requirements, guidances, and precedents.
• Manage regulatory queries and commitments, works with experts on responses, and provides regular status updates.
• Identifies regulatory risks and creates mitigation plans.
• Develop and draft regulatory strategy components, analyses, and position statements.
• Interpret health authority feedback and propose recommended paths forward for internal discussion.
• Provide routine regulatory guidance to cross-functional teams on applicable regulations, guidances, and precedents.
• Manage day-to-day regulatory activities and timelines for assigned deliverables. 

Requirements

• Bachelor’s degree in life sciences or related field.
• Advanced degree (doctorate or masters) is preferred.
• At least 2 years in regulatory strategy.
• Ex-US regulatory submission experience.
• Understanding of global regulatory frameworks (FDA, EMA, ICH).
• Excellent written and verbal communication skills.
• Advanced proficiency with Word. 

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