Regulatory Submissions Publisher — Remote & Growth

Freyr Solutions; Colombia; Presencial; COP 52.000.000 - 84.000.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible remote work

Professional development

Paid time off

Collaborative environment

Descripción de la vacante

Freyr Colombia SAS is a leading regulatory solutions provider, delivering end-to-end support across strategy, intelligence, dossiers, submissions, and post-approval activities. The Regulatory Submission Publisher role focuses on producing compliant publishing deliverables for US and global submissions, performing quality control, and coordinating activities across cross-disciplinary teams.

You will contribute to the preparation, submission tracking, and archival of documents, while staying

Formación

• 2+ years of experience in regulatory operations, including formatting, publishing, submitting, lifecycle management, and archiving regulatory submission sequences.
• Experience with document management systems and regulatory publishing tools is preferred.
• Ability to manage time-sensitive regulatory submissions and meet deadlines.
• Familiarity with NDAs/MAAs/NDSs and eSubmissions.

Responsabilidades

• Produce regulatory publishing deliverables (INDs, NDAs, NDSs, MAAs, annual reports, routine submissions) using electronic publishing tools and an EDMS.
• Perform independent publishing QC and complete checklists for submission readiness.
• Coordinate regulatory publishing activities with multidisciplinary teams.
• Provide expertise on regulatory publishing and authoring activities.
• Support preparation, submission, tracking, and archival of electronic and paper submissions.
• Assist in developing operations work instructions and participate in tool UAT and evaluations.
• Stay updated with regulatory standards and industry guidance.

Conocimientos

Regulatory publishing

Submissions management

Document management

Time management

Communication

Herramientas

Lorenz docuBridge

InSight Publisher

Lorenz eValidator

GlobalSubmit Validate

GlobalSubmit Review

ISI Toolbox

Microsoft Office

SharePoint

Descripción del empleo

Freyr Colombia SAS is a leading regulatory solutions provider, delivering end-to-end support across strategy, intelligence, dossiers, submissions, and post-approval activities. The Regulatory Submission Publisher role focuses on producing compliant publishing deliverables for US and global submissions, performing quality control, and coordinating activities across cross-disciplinary teams.

You will contribute to the preparation, submission tracking, and archival of documents, while staying