eCTD Regulatory Publisher

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, Global 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 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 publishing and authoring activities. Provide support for preparation, submission, tracking, and archival of electronic and paper submissions. Assist with development of assigned regulatory operations work instructions. Perform User Acceptance Testing (UAT) for publishing tools, as required. Participate in new technology evaluation for regulatory publishing needs. Stay abreast with updates for regulatory and/or industry standards. Required Competencies Overall knowledge of FDA/EMA/HC/SwissMedic/TGA/MHRA/MedSafe regulations/guidance and industry standards for electronic and paper submissions. Strong background in regulatory operations, including formatting, publishing, submitting, life‐cycling, and archiving sequences. Demonstrated performance in managing and producing time‐intensive deliverables. Knowledge of Document Management Systems (Documentum‐based is preferred) and publishing tools (e.g., Lorenz docuBridge, InSight Publisher, Lorenz eValidator, Global Submit Validate, Global Submit Review, and ISI Toolbox). Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint. Recent experience with NDAs / MAAs/ NDSs and document level publishing is essential.

Benefits:
Competitive salary Flexible remote work options Comprehensive health insurance Opportunities for professional development and growth Paid time off and holidays Supportive and collaborative work environment Join our team at Freyr Colombia SAS and make a significant impact in the world of regulatory submissions