Senior Documentation Specialist
Avetix Engineering, Trenton, NJ, United States
Specialist III, Regulatory Documentation – Biotechnology | Summit, NJ (On‑Site)
Location:
Summit, NJ. fully on‑site, Monday–Friday
A commercially-stage, publicly traded biopharmaceutical company headquartered in California is seeking a
Specialist III, Regulatory Documentation
to join their growing Regulatory Affairs team. This organization is at the forefront of immunotherapy and cell therapy innovation, with an FDA Breakthrough Therapy‑designated product already on the market.
Why This Opportunity?
Work on cutting‑edge oncology and infectious disease therapeutics at a company with a first‑in‑class, FDA‑approved product
Join a collaborative, cross‑functional team with room for professional growth
Publicly traded company offering stability and visibility in the biotech space
The Role Reporting to the Director of Regulatory Documentation, you will manage and publish regulatory submissions ensuring full compliance with Health Authority requirements. You'll play a key role in coordinating eCTD modules and supporting teams across the organization.
Key Responsibilities
Manage electronic project folders and maintain a Regulatory Information Management (RIM) system
Format, QC, and compile documents per regulatory agency requirements
Publish documents with internal bookmarks, hyperlinks, and XML backbone integration
Create and manage new submissions in publishing software per SOPs
Submit documents directly to Health Authorities
Advise internal departments on regulatory documentation best practices
Support training of junior Regulatory Documentation Specialists
Requirements
Bachelor's in Life Sciences or technical field + 5 years of regulatory operations experience in biotech/pharma,
OR
high school diploma + 9 years of equivalent experience
Expert knowledge of eDMS and Health Authority submission procedures
Strong working knowledge of Veeva Vault / Veeva RIM
Ability to manage tight deadlines and shifting priorities
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Summit, NJ. fully on‑site, Monday–Friday
A commercially-stage, publicly traded biopharmaceutical company headquartered in California is seeking a
Specialist III, Regulatory Documentation
to join their growing Regulatory Affairs team. This organization is at the forefront of immunotherapy and cell therapy innovation, with an FDA Breakthrough Therapy‑designated product already on the market.
Why This Opportunity?
Work on cutting‑edge oncology and infectious disease therapeutics at a company with a first‑in‑class, FDA‑approved product
Join a collaborative, cross‑functional team with room for professional growth
Publicly traded company offering stability and visibility in the biotech space
The Role Reporting to the Director of Regulatory Documentation, you will manage and publish regulatory submissions ensuring full compliance with Health Authority requirements. You'll play a key role in coordinating eCTD modules and supporting teams across the organization.
Key Responsibilities
Manage electronic project folders and maintain a Regulatory Information Management (RIM) system
Format, QC, and compile documents per regulatory agency requirements
Publish documents with internal bookmarks, hyperlinks, and XML backbone integration
Create and manage new submissions in publishing software per SOPs
Submit documents directly to Health Authorities
Advise internal departments on regulatory documentation best practices
Support training of junior Regulatory Documentation Specialists
Requirements
Bachelor's in Life Sciences or technical field + 5 years of regulatory operations experience in biotech/pharma,
OR
high school diploma + 9 years of equivalent experience
Expert knowledge of eDMS and Health Authority submission procedures
Strong working knowledge of Veeva Vault / Veeva RIM
Ability to manage tight deadlines and shifting priorities
#J-18808-Ljbffr