Specialist III, Regulatory Lifecycle Maintenance

ImmunityBio, Inc. • Summit, NJ

6d • Onsite

About The Position

The Specialist III, Regulatory Lifecycle Maintenance is responsible for assisting in the development of global clinical regulatory strategy for investigational and marketed products and assists with the preparation of dossiers in eCTD format. This role will provide a high level of expertise to the organization in ensuring the conduct of clinical trials conform to Health Authority requirements.

Requirements

• Bachelor’s degree in life sciences or a related field required; 5+ years of relevant regulatory clinical Science experience is required, or Master’s degree in life sciences or a related field required; 3+ years of relevant regulatory clinical Science experience is required
• Knowledge of Health Authority clinical guidance documents and requirements
• Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines
• Strong knowledge of clinical documentation
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Strong organizational skills, written and oral communication skills, and attention to detail

Nice To Haves

• Experience in the preparation of the submission of clinical modules in eCTD format is preferred
• Familiar with organizing responses to Health Authority information requests is preferred
• Familiarization with regulatory submissions internationally is preferred.

Responsibilities

• Prepare or review documents including investigator brochures, protocols, clinical study reports , annual reports, DSURs, PAERs, clinicaltrials.gov entries, and other lifecycle maintenance documents.
• Compile, organize, and catalogue essential regulatory documents on all active clinical studies to maintain compliance with Health Authorities.
• Review, edit and approve all final submissions to Health Authorities.
• Assist in daily operations outside of essential BLAs and provide regulatory input on day-to-day issues and provide regulatory documents to other departments.
• Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan.
• Assemble the reporting of clinical studies performed by IBRX or by CROs.
• Draft written summaries for regulatory submissions including but not limited to, INDs, NDAs, and BLAs.
• Provide support and training to others in the preparation, analysis, and documentation of studies.
• Draft and review essential BLA documents (ISS, ISE, CSRs, Label, Module 2.5), appendix cataloguing, and reconciliation.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Benefits

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO) includes: 11 Holidays
• Exempt Employees are eligible for Unlimited PTO
• Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level