Regulatory Documentation Specialist III

Specialist III, Regulatory Documentation

Responsibilities:
- Create and maintain electronic project folders; generate working electronic files
- Advise internal departments on preparation and submission of regulatory documentation
- Format and compile documents to regulatory and style guide requirements
- QC documents (formatting, bookmarking, hyperlinking, document properties)
- Create new submissions in submission software per SOPs and complete checklists
- Publish documents (bookmarks/hyperlinks), insert into XML backbone (docuBridge), and complete external XML backbone hyperlinks
- Submit documents to Health Authorities
- Maintain organized working files, forms, signout sheets, and archives per SOPs and Health Authority requirements
- Prepare templates/document shells for text and data inclusion
- Assist in training Regulatory Documentation Specialists and provide post-training support
- Support upgrades/new/removal of regulatory documentation software; perform ad-hoc/cross-functional duties

Qualifications:
- Bachelor’s in life sciences/technical discipline with 5+ years regulatory operations in biotech/pharma (required), or High school diploma with 9+ years (required)

Skills/Abilities:
- Expert knowledge of Health Authority electronic submission/document management procedures
- Expert knowledge of Electronic Document Management Systems
- Strong Veeva Vault (Veeva RIM)
- Ability to meet deadlines, adapt to changing requirements; strong organization, communication, attention to detail

Location/Work Schedule:
- On-site (Mon–Fri), Summit, NJ

Comp/Benefits (if applicable):
- Discretionary bonus and equity; hourly base pay: $50.48–$55.53
- Medical, dental, vision and wellness benefits; PTO (11 holidays), 401(k) match, EAP, etc.

Application instructions:
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).