CMC Specialist – Module 3 Authoring

Freyr Solutions is a leading global Regulatory Solutions and Services company supporting Life Sciences organizations across pharmaceuticals, biologics, medical devices, and consumer healthcare industries.

Job Title

CMC Analyst – Module 3 Authoring

Location

Bogota, Colombia

Employment Type

Full‑Time / Indefinite

Overview

Freyr’s client requires a hands‑on CMC Analyst with direct experience authoring technical CMC documentation for global regulatory submissions, focusing on Module3 CTD content.

Responsibilities

• Author and develop Module3 CTD sections for Drug Substance (S) and Drug Product (P).
• Prepare technical CMC documentation, including manufacturing process descriptions, specifications, analytical methods, stability summaries and protocols, process validation documentation, and impurity control strategies with justifications.
• Interpret and analyze batch records, validation re...