Manager, Veeva RIM

ImmunityBio, Inc.•Summit, NJ

20h•$165,000 - $181,500•Onsite

About The Position

The Manager, Veeva RIM will provide strategic and strategic leadership and oversight for Veeva RIM. The manager will manage the day-to-day management and operations of Veeva RIM, ensuring accurate, timely, and compliant uploads and maintenance of regulatory submissions and related documentation across US and ex-US regions. This role parents closely with Clinical, Nonclinical, and CMC regulatory teams to support all regulatory activities. This position will assist and direct staff in the use of Veeva RIM software to ensure that all regulatory content, submissions, and processes are managed efficiently, accurately, and in full compliance with global regulations.

Requirements

Bachelor’s Degree in life sciences or technical discipline with 7+ years of regulatory operation experience in the biotech or pharmaceutical industry required; or High School diploma with 11+ years of regulatory operation experience in the biotech or pharmaceutical industry required.
Familiarity with global regulatory submissions (US and ex-US).
2 years of experience managing regulatory documentation using Veeva RIM required.
Leadership skills with the ability to direct and develop professional staff
Strong knowledge of Health Authority guidance documents and requirements.
Strong knowledge of Health Authority procedures and guidance regarding document management and electronic submission.
Strong knowledge of the use of Veeva RIM in document management.
Strong attention to detail and document management skills.
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

2+ years of experience managing staff in support of Regulatory Affairs operations is preferred.

Responsibilities

Lead the Regulatory Affairs Veeva RIM Team by delegating projects, establishing and meeting timelines, and ensuring high quality work products.
Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees, and monitoring performance.
Manage dossier archiving and ensure regulatory data integrity, version control, and audit readiness.
Use Veeva RIM to upload and manage all regulatory submissions (e.g., BLA, IND, CTA), registrations, and archival of documents for both US and ex-US.
Upload, track, and maintain all correspondence with health authorities as well as ethic committees.
Partner with IT, Quality, and clinical on system support activities as needed.
Partner with IT, Quality, and clinical on system validation, upgrades, and testing, ensuring compliance with GxP and regulatory standards.
Ensure all regulatory questions, requests, and responses are accurately uploaded and linked properly in Veeva RIM.
Upload and maintain all Word and source documents in the Veeva Vault to enable version control, collaboration, and document updates.
Manage documents received but not limited to via regulatory gateways, emails, secure links.
Establish and maintain RIM-related SOPs, work instructions, and best practices.
Lead or support migration of regulatory and submission documents from legacy systems to Veeva.
Maintain full lifecycle document management: authoring, reviewing, approval, version control, metadata, retention.
Track regulatory submission renewals, post-approval changes, and ensure timelines are met.
Monitor regulatory guidance and changes, perform impact assessment; communicate changes to cross-functional teams.
Ensure compliance with relevant regulatory requirements (FDA, EMA, ICH, local authorities)
Ensure that all working files and archives are organized and maintained in accordance with SOPs and Health Authority requirements
Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications.
Provide user support/training for Veeva workflows; act as tool superuser.
Train and support cross-functional uses on Veeva RIM processes and document standards.
Prepare for internal/external audits, inspections, and data integrity assessments, address findings promptly.
Act as a point of contact for troubleshooting Veeva RIM issues and coordinating with system administrators.
Performs ad-hoc and cross-functional duties and/or projects 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