Regulatory Operations Expert

**Job Overview:** Scientific Writer with strong expertise in material science, analytical chemistry, and chemical principles (organic and inorganic) as applied to pharmaceutical formulation, manufacturing, and product lifecycle management. This role serves as a scientific authority for translating material, analytical, and process knowledge into robust, lifecycle ready CMC documentation. The position is a key enabler of knowledge capture, scientific consistency, and regulatory defensibility across technology transfer, PPQ, and commercial manufacturing. You work at the interface of science, manufacturing, quality, and regulatory, ensuring that how we understand materials and processes is clearly articulated, justified, and sustained throughout the product lifecycle **Summary of Responsibilities:** These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally. **Scientific Leadership & CMC Knowledge Translation** - Act as a **scientific owner** for the development of **high‑quality CMC documentation**related to: - Pharmaceutical raw materials and excipients - Process aids and contact materials (incl. leachables & extractables) - Material changes, supplier changes, and lifecycle optimization activities - Translate **complex analytical, chemical, and manufacturing data**into: - Scientifically rigorous justifications - Risk assessments and material qualification reports - CMC sections supporting variations, supplements, and regulatory responses - Ensure scientific content is **aligned with Quality‑by‑Design principles**and clearly supports: - Control strategies - Defined design space and material attribute justifications - Lifecycle change management **Analytical Chemistry & Chemical Understanding** - Integrate and critically interpret **analytical chemistry data**, including: - Physicochemical characterization - Impurity and degradation profiles - Elemental and inorganic contaminants - Comparability and trend analyses - Apply **organic and inorganic chemistry principles**to: - Assess material composition, chemical reactivity, and degradation pathways - Evaluate compatibility with formulations, processes, and packaging systems - Support scientifically sound impurity and risk justifications - Identify analytical **data gaps** and define scientifically appropriate strategies to close them, in collaboration with analytical development and external laboratories. **Manufacturing Processes, Unit Operations & MSAT Lifecycle Support** - Provide scientific assessments on the **impact of material attributes on pharmaceutical manufacturing processes and unit operations**, including: - Blending, granulation, drying, compression, coating - Mixing, filtration, emulsification, sterilization (as applicable) - Support **technology transfer, PPQ, and commercial manufacturing**by: - Documenting material‑process interactions - Supporting root cause investigations and comparability assessments - Providing scientific rationales for process or material changes - Ensure scientific conclusions reflect **manufacturing reality**, robustness, and process capability, not only laboratory observations. **Lifecycle Management, Compliance & Regulatory Alignment** - Ensure documentation is fully **aligned with global regulatory and compliance expectations**, including: - ICH Q8–Q12 principles - Pharmacopeial requirements - GMP expectations for materials, suppliers, and change management - Support **regulatory submissions, variations, and health authority interactions**by: - Providing clear, defensible scientific rationales - Ensuring consistency between analytical data, process understanding, and CMC narratives - Maintain strong **traceability** between experimental data, conclusions, and regulatory positions throughout the product lifecycle. **Cross‑Functional Scientific Collaboration** - Act as a **scientific interface** between…