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 reports, stability data, and analytical testing data. Translate scientific and manufacturing information into regulatory‑compliant CMC content. Support technical CMC activities for global submissions, lifecycle management, and variations. Ensure alignment with FDA, EMA, and global regulatory expectations. Collaborate with manufacturing, quality, analytical development, and regulatory teams. Participate in technical document reviews and quality checks to ensure accuracy and consistency. Qualifications Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or a related scientific discipline. Proven experience authoring technical CMC content for Module3 submissions. Hands‑on experience with manufacturing data, stability studies, validation reports, and analytical method documentation. Strong understanding of Drug Substance (DS), Drug Product (DP), and CTD/eCTD structures. Experience supporting FDA, EMA, or global regulatory submissions. Experience in pharmaceutical manufacturing, quality, analytical development, or technical regulatory authoring environments preferred. Technical Skills Strong working knowledge of ICH Q1 – Stability. ICH Q2 – Analytical Validation. ICH Q3 – Impurities. ICH Q6 – Specifications. ICH Q8 / Q11 – Pharmaceutical Development. CTD/eCTD authoring standards. GMP documentation principles. Soft Skills Strong technical writing and analytical interpretation skills. Strong attention to detail and scientific accuracy. Ability to work effectively with cross‑functional global teams. Good communication and collaboration skills. Language English proficiency required. Spanish proficiency preferred. Benefits Opportunity to work with global pharmaceutical clients. Exposure to international regulatory environments and submissions. Collaborative and growth‑oriented work environment. Opportunity to work on high‑impact global regulatory projects. #J-18808-Ljbffr