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The Regulatory Affairs Senior Associate will work at the interface of R&D and Regulatory, building a genuine technical understanding of the product's formulation and analytical profile to support sound regulatory strategy. This is not a document-processing role — it requires the ability to engage with development science, identify potential issues, and contribute informed regulatory thinking rather than just administrative submission support. Responsibilities Develop a working technical understanding of assigned products — formulation composition and rationale, manufacturing process, and analytical/impurity profile — sufficient to identify regulatory implications independently. Review R&D and Analytical data, including formulation trials, stability studies, method validation and characterization data, critically to spot gaps, inconsistencies or risks. Support the Manager/Director in framing regulatory strategy by contributing well-reasoned technical inputs. Assess the regulatory impact of significant development changes and ensure that comparability, bridging or additional evidence requirements are addressed prospectively. Prepare and/or review assigned dossier sections, briefing packages and responses to major authority questions, ensuring completeness. Drive submission readiness, including gap closure, review cycles, issue escalation and completion against agreed milestones.