Explore CMC Officer jobs and discover a pivotal career at the intersection of science, manufacturing, and global compliance in the pharmaceutical and biotechnology industries. A Chemistry, Manufacturing, and Controls (CMC) Officer is a specialized regulatory professional responsible for ensuring that the detailed scientific data governing a drug's composition, production, and quality control are meticulously documented, maintained, and submitted to health authorities worldwide. This role is critical for navigating the complex pathway of bringing new medicines to market and maintaining the lifecycle of existing products. Professionals in these jobs act as the central hub for all CMC-related regulatory information. Their core mission is to compile, update, and manage the chemistry, manufacturing, and controls sections (primarily Module 3) of regulatory submission dossiers, such as the Common Technical Document (CTD). They ensure every detail about the drug substance and product—from raw material specifications and manufacturing processes to analytical testing methods and stability data—is accurate, complete, and compliant with evolving regional regulations. A typical day involves writing and reviewing technical documents, preparing variation packages for post-approval changes, and responding to detailed questions from regulatory agencies. CMC Officers meticulously track the lifecycle of a product, managing renewals, variations, and ensuring all CMC documentation is perpetually audit-ready. Collaboration is a cornerstone of this profession. CMC Officers work closely with cross-functional teams, including Regulatory Affairs (RA), Research & Development (R&D), Quality Assurance (QA), and manufacturing sites. They translate complex technical data from scientists and engineers into structured regulatory language acceptable to authorities. When regulatory queries arise, they coordinate the response, gathering necessary data and clarifications from internal and external stakeholders to ensure timely and comprehensive replies. Typical requirements for CMC Officer jobs include a bachelor’s or advanced degree in Chemistry, Pharmacy, Biochemistry, Chemical Engineering, or a related life science. Employers typically seek candidates with several years of experience in a CMC, regulatory, or pharmaceutical development role. Essential skills include an exceptional eye for detail, superb technical writing ability, and a strong understanding of ICH guidelines, GMP (Good Manufacturing Practice), and regional regulatory frameworks. Proficiency in document management systems and electronic submission tools (eCTD) is often required. Excellent project management and communication skills are vital, as the role demands managing multiple deadlines and facilitating clear information flow between technical and regulatory colleagues. For scientists who excel at organization and have a passion for ensuring drug quality and safety, CMC Officer jobs offer a stable, challenging, and highly impactful career path, essential to the global pharmaceutical supply chain.
