Manager, Project Management, Regulatory

BioSpace; New Jersey; On-site; USD 111,000 - 145,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Parental leave

Job summary

Legend Biotech in Somerset, NJ seeks a Manager, Regulatory Project Management to coordinate cell and gene therapy development programs. You will work with Research, CMC, Quality, Regulatory Affairs, Clinical Operations and external partners to keep timelines on track and ensure milestones are met.

Reporting to the Director of Project Management Regulatory, you will manage meeting materials, dashboards, budgets and onboarding.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or related field; Master's preferred.
• 1–3 years in project coordination, project management, program support, or administrative project support within biotech/pharma.
• Familiarity with Cell & Gene Therapy, biologics, or related therapeutic development is preferred.
• Experience working in cross-functional teams within a regulated environment is preferred.
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• Excellent written, verbal, and interpersonal communication skills; PMP or CAPM is a plus but not required.

Responsibilities

• Coordinate day-to-day project activities across cross-functional teams, including Research, CMC, Quality, Regulatory Affairs, Clinical Operations, and external partners.
• Develop and maintain project timelines, action-item trackers, meeting agendas, and other key project documentation.
• Schedule and facilitate project team meetings, prepare meeting minutes, and follow up on action items to support timely completion.
• Monitor project progress and promptly escalate potential risks, delays, and resource constraints to project leadership.
• Support the preparation and coordination of activities related to IND submissions and other regulatory filings.
• Track project budgets, purchase orders, invoices, and resource utilization in collaboration with Finance and functional leads.
• Assist with preparation of project dashboards, presentations, reports, and materials for leadership reviews and governance meetings.
• Assist with onboarding new project team members by coordinating access to systems, project documentation, and team resources.
• Provide general administrative support to the cross function as needed.
• Support vendor onboarding, contract routing, purchase requisitions, and invoice processing in partnership with Procurement and Finance.
• Facilitate clear, effective communication among internal stakeholders and external collaborators (CROs and CDMOs).
• Ensure project documentation is accurate, well organized, and maintained per company procedures.
• Contribute to continuous improvement of PM processes, templates, and best practices.

Skills

Project coordination

Cross-functional teamwork

Communication

Organizational skills

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Project

Smartsheet

Microsoft Office

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 a Manager, Regulatory Project Management as part of the Regulatory team based in Somerset, NJ.

Role Overview

This role will be reporting to the Director of Project Management Regulatory. We are seeking a motivated, detail-oriented Project Manager to support the planning and execution of Cell & Gene Therapy development programs. Working closely with cross-functional teams, this individual will coordinate project activities, monitor timelines, facilitate effective communication, and provide administrative support to ensure projects are executed efficiently and meet key development milestones. This opportunity is well suited to an individual with early-career project management experience in the biotechnology or pharmaceutical industry who is eager to grow in a fast-paced, collaborative environment. The successful candidate will play a key role in project coordination, documentation, meeting management, and operational support throughout the product development lifecycle.

Key Responsibilities

• Coordinate day-to-day project activities across cross-functional teams, including Research, CMC, Quality, Regulatory Affairs, Clinical Operations, and external partners.
• Develop and maintain project timelines, action-item trackers, meeting agendas, and other key project documentation.
• Schedule and facilitate project team meetings, prepare meeting minutes, and follow up on action items to support timely completion.
• Monitor project progress and promptly escalate potential risks, delays, and resource constraints to project leadership.
• Support the preparation and coordination of activities related to Investigational New Drug (IND) submissions and other regulatory filings.
• Track project budgets, purchase orders, invoices, and resource utilization in collaboration with Finance and functional leads.
• Assist with preparation of project dashboards, presentations, reports, and materials for leadership reviews, governance meetings, and investor or partner updates.
• Assist with onboarding new project team members by coordinating access to systems, project documentation, and team resources.
• Provide general administrative support to the cross function as needed.
• Support vendor onboarding, contract routing, purchase requisitions, and invoice processing in partnership with Procurement and Finance.
• Facilitate clear, effective communication among internal stakeholders and external collaborators, including contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs).
• Ensure project documentation is accurate, well organized, and maintained in accordance with company procedures.
• Contribute to the continuous improvement of project management processes, templates, and best practices.

Requirements

• Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or a related scientific field. Masters degree preferred.
• 1–3 years of experience in project coordination, project management, program support, or administrative project support within the biotechnology, pharmaceutical, or life sciences industry.
• Familiarity with Cell & Gene Therapy, biologics, or related therapeutic development is preferred.
• Basic understanding of the drug development process, including preclinical development, CMC activities, and IND submissions.
• Experience working in cross-functional teams within a regulated environment is preferred.
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• Excellent written, verbal, and interpersonal communication skills.
• Proficiency with Microsoft Office (Excel, PowerPoint, Word) and project management tools such as Microsoft Project, Smartsheet, or similar platforms.
• PMP or CAPM certification is a plus but not required.

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)

$110,706 - $145,303 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.