About Freyr Colombia SAS:

Freyr Colombia SAS is the largest global Regulatory Solutions & Services provider, supporting large, mid, and small global Life Sciences companies in their entire Regulatory value chain. Our services range from Regulatory Strategy, Intelligence, Dossiers, Submissions, to Post-Approval/Legacy Product Maintenance, Labeling, Artwork Change Management, and other related functions.

Our Specialties:

Include Regulatory Consulting & Strategy, Regulatory Operations & Affairs, Regulatory Software Solutions, Regulatory Information & Intelligence, Integral Regulatory Responsibility Services, Regulatory Publishing & Submission, Regulatory Medical Writing, IDMP, Medical Devices Regulatory Services, Regulatory Artwork & Labeling, CMC, and more.

With over 1,370 global clients and a presence in over 22 countries, Freyr leverages its expertise to provide comprehensive regulatory support, including intelligence-driven submissions, product registrations, labeling, artwork, post-approval change management, and regulatory software.

Job Title: Regulatory Submission Publisher





Location: Bogotá, Colombia (Remote)

Job Type: Permanent/Indefinite

Job Description
for Life Cycle management and Original Dossier Development

Essential duties and responsibilities (included but not limited to the following (Other duties may be assigned):

Produce regulatory publishing deliverables (e.g., INDs, NDAs, NDSs, MAAs, annual reports, routine submissions, Clinical Study Reports) in accordance with US and global requirements, using electronic publishing tools, and an EDMS system.

Perform independent publishing QC on published output, complete appropriate checklists and/or provide assessments for the activities around the quality of document‐level publishing and submission readiness of source documents for submission‐level publishing.

Act as a liaison while coordinating regulatory publishing activities with other multidisciplinary teams.

Provide expertise on regulatory publis

📌 Regulatory Submission Publisher Colombia
🏢 Freyr Solutions
📍 Colombia