---
title: 'Associate Director, Regulatory Affairs at Legend Biotech US'
canonical: 'https://feeny.ai/job/associate-director-regulatory-affairs-legend-biotech-us-somerset-hkh7d6s5fwv1'
type: 'job'
last_seen: '2026-10-15'
---

# Associate Director, Regulatory Affairs at Legend Biotech US

- **Company:** Legend Biotech US
- **Location:** Somerset, NJ
- **Compensation:** $168k–$221k
- **Posted:** 2026-10-05
- **Last confirmed live:** 2026-10-15
- **Apply:** https://job-boards.greenhouse.io/legendcareers/jobs/4740414005

## Job description

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking an Associate Director, Regulatory Affairs as part of the Regulatory Affairs team based in Somerset, NJ.

## Role Overview

The Associate Director of Regulatory Affairs is responsible for independently developing, coordinating and executing the global regulatory strategies. The Associate Director will represent Regulatory Affairs on global cross-functional teams and provide oversight on regulatory strategy implementation for the assets. The Associate Director will interact with health authorities to seek feedback and reach alignment on regulatory strategies; oversee activities for regulatory filings and ensure timely and high-quality submissions. The Associate Director will also work closely with collaboration partner on a key asset.

## Key Responsibilities

- Responsible to independently develop innovative, robust global regulatory strategies and ensure their efficient and effective execution for Legend pipeline programs.
- Lead the team efforts required for the submission of INDs, CTAs, and BLAs as well as related supplements/variations; ensure timely and high-quality submissions.
- Lead the effort to evaluate the need to develop in-vitro diagnostic test or companion diagnostic tests for pipeline programs as needed.
- Oversee the maintenance of INDs, CTAs and BLAs, and ex-U.S. filings as required.
- Interface with the FDA and other health authorities to seek feedback and alignment on pre-clinical and clinical development strategies.
- Serves as regulatory representative in global cross-functional development teams for pipeline programs; work closely with other line functions to ensure efficient execution of regulatory strategies.
- Serve as regulatory representative in internal cross-functional teams for activities such as SOP development, business process improvements, etc.
- Represent Legend regulatory affairs in external collaborations.
- Serve as the regulatory affairs reviewer in the promotional material review committee.
- Coach and mentor junior members in their roles on global project teams.
- Have a good understanding of the competitive regulatory landscape in oncology, immunology and cell therapy.
- Provides regular and timely updates to management on the status of all pending applications and planned submissions as necessary.

## Requirements

- A Pharm D or PhD Degree, or equivalent in a science or health care field is required
- A minimum of 5+ years of experience in regulatory affairs in drug development, focusing on filing and approval process in IND/CTA/BLA/MAA
- Broad and in-depth knowledge of global regulatory requirements and regulations on drug development, experience in biologics and cell therapies is preferred
- Ability to independently formulate and lead the team to execute global regulatory strategies
- Experienced in the preparation of major regulatory submissions,amendments and supplements in US and ex-US countries
- Good understanding on CDx development
- Able to think out of the box, formulate innovative regulatory strategies to speed up clinical development
- Demonstrate excellent communication skills.
- Demonstrate strong organizational skills, including the ability to prioritize
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, clinical, and manufacturing representatives
- Experience in cell and gene therapy is a plus
- Experience in drug development in multiple myeloma is a plus
- Language(s): English

#Li-AS1

#Li-Hybrid 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.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: 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 voluntary 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 voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay): $168,372—$220,988 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

## EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](https://legendbiotech.com/privacy-notice/).

## About Legend Biotech US

## Company Overview
- **One-liner**: Legend Biotech is a global, commercial-stage biotechnology company developing advanced cell therapies, including CAR-T, TCR-T, and NK cell-based immunotherapies, to treat and cure life-threatening diseases.
- **Entity Type**: Public (NASDAQ: LEGN) – commercial-stage with approved product
- **Headquarters**: Somerset, New Jersey, United States (Global HQ at 2101 Cottontail Lane, Somerset, NJ 08873)
- **Founded**: 2014
- **Founders**: Not publicly available in provided sources

## Core Business
- **Primary industry**: Biotechnology – cell and gene therapy, oncology
- **Target customers**: Patients with hematologic and solid tumors; partners include healthcare providers, payers, and pharmaceutical companies (B2B/B2C)
- **Mission**: “To become the global leader in cell and gene therapy” – creating transformative therapies that change treatment paradigms, with a vision of a future where cancers and intractable diseases are curable. [legendbiotech.com](https://legendbiotech.com/mission-vision-values/)

## Products & Services
- **Carvykti (ciltacabtagene autoleucel / cilta-cel)**: An approved CAR-T therapy for multiple myeloma, developed and commercialized in a global collaboration with Janssen (Johnson & Johnson). [legendbiotech.com](https://legendbiotech.com/)
- **Pipeline of cell therapies**: Includes autologous and allogenic CAR-T, TCR-T, and NK cell-based candidates targeting hematologic and solid tumors. Legend Biotech is technology-agnostic and focuses on intractable/incurable diseases. [legendbiotech.com](https://legendbiotech.com/)
- **End-to-end capabilities**: From discovery through commercialization, including R&D (three global sites), manufacturing, and supply chain. [legendbiotech.com](https://legendbiotech.com/)

## Market Standing
- **Valuation / Market Cap**: Not disclosed in provided sources
- **Key Metric**: Over 10,000 patients treated to date with Carvykti; team of 3,000+ employees. [legendbiotech.com](https://legendbiotech.com/)
- **Notable Investors / Partners**: Janssen (Johnson & Johnson) – strategic collaboration for co-development and commercialization of cilta-cel. [greenhouse.io](https://job-boards.greenhouse.io/legendcareers)
- **Growth Signals**: Commercial-stage with approved product; expanding pipeline into solid tumors; global presence with facilities in New Jersey (Somerset, Piscataway), Nanjing (China), Dublin (Ireland), and Ghent (Belgium). [legendbiotech.com](https://legendbiotech.com/contact-us/)

## Competitive Advantages
- **Proven CAR-T platform**: Carvykti is a best-in-class therapy for multiple myeloma, with strong clinical data and real-world outcomes.
- **Technology agnostic**: Invests in multiple cell therapy modalities (CAR-T, TCR-T, NK) to address diverse targets and tumor types.
- **End-to-end integration**: Controls the entire value chain from R&D to commercial manufacturing, enabling speed and quality.
- **Global collaboration with Janssen**: Combines Legend’s innovation with Janssen’s development and commercial infrastructure.

## Strategic Focus
- **Pipeline expansion**: Advancing cell therapies into solid tumors and earlier lines of treatment.
- **Manufacturing scale-up**: Building internal and external manufacturing capacity to meet growing demand.
- **Global reach**: Expanding commercial footprint beyond the US and Europe (e.g., China, rest of world).
- **Continuous innovation**: Pursuing next-generation cell therapies (allogenic, off-the-shelf, etc.) to improve patient access and outcomes.

## Why Work Here
- **Culture**: Driven by four core behaviors – Continuous Improvement, Agility & Prioritization, Teamwork & Communication, Ownership & Commitment. Emphasis on integrity, patient-first, innovation, one team, and result-driven values. [legendbiotech.com](https://legendbiotech.com/careers/)
- **Benefits**: Total Rewards approach including medical, dental, vision, 401(k), generous paid leave, and a comprehensive wellbeing package covering physical, mental, financial, community, mobility, and purpose pillars. [legendbiotech.com](https://legendbiotech.com/careers/)
- **Work environment**: Global, collaborative, and diverse. Equal opportunity employer with a focus on inclusion. Roles span R&D, manufacturing, quality, commercial, and corporate functions. [greenhouse.io](https://job-boards.greenhouse.io/legendcareers)
- **Growth opportunities**: Pay-for-performance compensation, continuous learning and development programs, leadership classes, and career mobility.
- **Location**: Hybrid/office roles based primarily in Somerset and Piscataway, NJ; also opportunities in Bridgewater, NJ, Philadelphia, PA, and international sites.

## Sources
1. [greenhouse.io](https://job-boards.greenhouse.io/legendcareers) – Jobs page with company description and open roles
2. [legendbiotech.com](https://legendbiotech.com/) – Company homepage (overview, pipeline, team size, patients treated)
3. [legendbiotech.com](https://legendbiotech.com/careers/) – Careers page (culture, benefits, total rewards)
4. [legendbiotech.com](https://legendbiotech.com/contact-us/) – Contact page (HQ and global locations, investor email)
5. [legendbiotech.com](https://legendbiotech.com/mission-vision-values/) – Mission, vision, and values page

## Other roles at Legend Biotech US

- [Sr. Manager, QC Microbiology](https://feeny.ai/job/sr-manager-qc-microbiology-legend-biotech-us-raritan-01dhvy4n8wmh) — Raritan, NJ
- [Director, Head of Commercial Training](https://feeny.ai/job/director-head-of-commercial-training-legend-biotech-us-united-states-0ybjn146k293) — United States
- [Sr. Cell Therapy Account Specialist, Salt Lake City](https://feeny.ai/job/sr-cell-therapy-account-specialist-salt-lake-city-legend-biotech-us-utah-zefrakpwk3jv) — Utah, United States
- [Sr. Cell Therapy Account Specialist, Rochester](https://feeny.ai/job/sr-cell-therapy-account-specialist-rochester-legend-biotech-us-new-york-j6vczz36v67d) — New York, NY
- [Sr. Cell Therapy Clinical Educator](https://feeny.ai/job/sr-cell-therapy-clinical-educator-legend-biotech-us-illinois-4yff0x10v7v2) — Illinois, United States
- [Sr. Cell Therapy Clinical Educator](https://feeny.ai/job/sr-cell-therapy-clinical-educator-legend-biotech-us-wisconsin-vbjqca6yap54) — Wisconsin, United States
- [Validation Specialist](https://feeny.ai/job/validation-specialist-legend-biotech-us-raritan-s312s7p9cycn) — Raritan, NJ
- [Sr. Cell Therapy Clinical Educator (New York)](https://feeny.ai/job/sr-cell-therapy-clinical-educator-new-york-legend-biotech-us-new-york-6vcde4qce9pq) — New York, NY
- [Receptionist](https://feeny.ai/job/receptionist-legend-biotech-us-somerset-sks1f1rgyhw6) — Somerset, NJ
- [US: Sr. Cell Therapy Clinical Educator (Gulf Coast)](https://feeny.ai/job/us-sr-cell-therapy-clinical-educator-gulf-coast-legend-biotech-us-louisiana-a632rjznwenx) — Louisiana, United States / Texas, United States