Senior Manager, Regulatory Strategy

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

 

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

 

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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The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles.

The anticipated base pay range is:$123,605—$162,232 USD

Benefits

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning a