Manager, Regulatory Lifecycle Maintenance

ImmunityBio•Summit, NJ

4d•Onsite

About The Position

The Manager, Lifecycle Maintenance will advance the maintenance global clinical regulatory compliance for investigational and marketed products and manage the maintenance of study files in eCTD format. This position will contribute to the organization in the design and conduct of clinical trials in conformance with Health Authority requirements and the management of clinical trial documentation to support clinical submissions.

Requirements

Bachelor’s Degree in life sciences or technical discipline with 7+ years relevant progressive experience required; or Master’s degree in life sciences or technical discipline with 5+ years relevant progressive experience required; or Doctorate degree in life sciences or technical discipline with 3+ years relevant progressive experience required
Experience managing staff preferred
Experience in the management and preparation of the submission of clinical modules in eCTD format required
Experience with organizing responses to Health Authority information requests required
Strong knowledge of Health Authority guidance documents and requirements
Strong leadership skills with the ability to direct and develop professional staff
Strong knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines
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

Familiarity with global regulatory submissions (US and ex-US) strongly preferred

Responsibilities

Lead Lifecycle Maintenance staff by delegating projects, establishing and meeting timelines, and ensuring high quality work products
Manage the day-to-day activities of staff to include the hiring and training of new team members, coaching employees and monitoring performance.
Provide input to the design and reporting of clinical studies performed by IBRX or by CROs
Manage the review, cataloguing, and submission of documents including investigator brochures, protocols, informed consent forms, clinical study reports, annual reports, DSURs, PSURs, PAERs, and clinicaltrials.gov entries in the US and abroad
Manage all protocol supportive documentation including the cataloguing and submission of essential investigator qualification documents
Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan
Create and maintain project plans for regulatory lifecycle maintenance operations
Monitor FDA and other health‑authority guidance, prepare supplemental dossiers, and manage the lifecycle documentation for post‑approval changes.
Lead data‑driven strategic initiatives to maintain comprehensive regulatory documentation, ensuring compliance and supporting organizational objectives.
Oversee configuration, maintenance, and user support for internal platforms used for file storage.
Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies
Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications
Manage the internal review of the relevant clinical sections of written summaries for regulatory submissions including INDs, NDAs, and BLAs
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
This position is eligible for a discretionary bonus and equity award.