Position SummaryThe Specialist III, Regulatory Documentation will report to the Director, Regulatory Documentation and will provide expertise and guidance in the management and publishing of documents ensuring their conformance with Health Authority requirements. This position will assist staff in the document management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules.
Essential Functions- Create and maintain electronic project folders for projects
- Serve as an advisor to internal departments in the preparation and submission of regulatory documentation
- Generate electronic files for working documents
- Format documents prepared or received according to stipulated style guides for reports, assessments, regulatory submissions, letters, etc.
- Format and compile documents according to requirements specified by Regulatory Agencies
- QC documents (formatting, bookmarking, hyperlinking, document properties) that were prepared by others
- Create new submissions in submission software following all SOPs and ensuring all checklists are completed
- Publish documents (internal bookmarks and hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks to other documents and datasets on the XML backbone
- Submit documents to Health Authorities.
- Ensure that all working files, forms, signout sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements
- Prepare templates and document shells for inclusion of text and data
- Assist in training Regulatory Documentation Specialists ensuring that all SOPs are followed, and all questions are answered; Continue to provide support and assist in questions after the training is completed
- Collaborate with other Regulatory Documentation Specialists regarding upgrades to existing software programs, new software programs, or removing software programs that are no longer needed
- Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
Education & Experience- Bachelor's Degree in life sciences or technical discipline with 5+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or
- High school diploma with 9+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required
Knowledge, Skills, & Abilities- Expert knowledge of Health Authority procedures and guidance regarding document management and electronic submission
- Expert knowledge of Electronic Document Management Systems
- Strong knowledge in Veeva Vault especially Veeva RIM
- 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
Working Environment / Physical Environment- This position works on-site (Monday through Friday) in Summit, NJ.
- Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.
- This position may need to sit for long periods of time and use various computer programs
- This desk-based role involves the close study of scientific and regulatory documents
- They will work closely with colleagues throughout the day, often on a project-team basis
This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.
$50.48 (entry-level qualifications) to $55.53 (highly experienced) per hour
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.
Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: 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 • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
