Associate Director, Regulatory Affairs

Legend Biotech US; New Jersey; Hybrid; USD 168.000 - 221.000; Vollzeit

Benefits dieser Stelle

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Paid parental leave

Paid time off

Zusammenfassung

Legend Biotech US in Somerset, NJ, seeks an Associate Director, Regulatory Affairs to lead global regulatory strategies for our cell therapy portfolio. You will interact with FDA and other health authorities, coordinate IND/CTA/BLA submissions, and drive regulatory strategy across cross-functional teams.

The role requires a PharmD or PhD with 5+ years of regulatory experience in drug development, with emphasis on biologics and cell therapies.

Qualifikationen

• PharmD or PhD in science/healthcare required.
• Minimum 5+ years in regulatory affairs for drug development with IND/CTA/BLA/MAA experience.
• Strong knowledge of global regulatory requirements for biologics and cell therapies.
• Ability to independently lead global regulatory strategies and teams.

Aufgaben

• Develop and coordinate global regulatory strategies for Legend pipeline programs.
• Lead IND/CTA/BLA submissions and related supplements, ensuring timely approvals.
• Evaluate need for in-vitro diagnostics or companion diagnostics as required.
• Maintain INDs/CTAs and ex-US filings; interface with FDA and health authorities.
• Represent Regulatory Affairs on cross-functional development teams and external collaborations.
• Coach and mentor junior team members.

Kenntnisse

Regulatory strategy leadership

IND/CTA/BLA filings

Global regulatory submissions

FDA/health authority liaison

Cross-functional collaboration

Mentoring junior staff

Oncology/cell therapy knowledge

Strategic thinking

Ausbildung

PharmD or PhD in science/healthcare

Jobbeschreibung

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
• Able to think out of the box, formulate innovative regulatory strategies to speed up clinical development
• 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

#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.

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.

• Access to Company Confidential Information. I acknowledge that for the sole and limited purpose of evaluating a possible employment relationship with me, the Company might disclose, or enable me to have access to, certain Confidential Information of the Company, as defined below. I agree that, except for purposes of evaluating a possible employment relationship with the Company or as expressly authorized in writing by the Company, I will (a)not use or disclose any Confidential Information; (b)keep all Confidential Information confidential at all times; and (c)not copy, reproduce or modify any Confidential Information.
• Definition of “Confidential Information.” For purposes of this Agreement, “Confidential Information” shall mean any and all information and materials provided to me by the Company, including without limitation, inventions, trade secrets, software code, product development and marketing strategies, ideas, processes, formulas, know-how, unpublished financial information, business plans, contractual relationships with third parties and operating strategies; memoranda, notes, records, drawings, manuals, disks, or other documents and media; and all embodiments, copies, extracts, and summaries thereof; provided, however, that “Confidential Information” shall not include information that: (a) is generally known or available to the public, or (b) is furnished to me by a third party who obtained such information using lawful means and without any restrictions on disclosure.
• Third Party Information. I agree that during the course of communications with the Company pursuant to this Agreement or in connection with my application and interviews for employment with the Company, I will not make any unauthorized use or disclosure to the Company of any confidential or proprietary information or trade secrets of any other person or entity to whom I have an obligation of confidentiality with respect to such information, including any current or former employer. I further agree not to provide to the Company any materials or documents of any third party that are not generally available to the public.
• Remedies for Breach. I acknowledge that in the