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
Requirements
Experience and Qualifications
Minimum 4 years of relevant pharmaceutical or biopharmaceutical industry experience
Minimum 2-3 years of genuine exposure in R&D;, either formulation development and/or analytical sciences
Required Skills
Understanding of and hands-on experience with regulatory dossier structure and requirements, including CTD/eCTD, is preferred, though the primary emphasis of this role is technical/scientific understanding over document compilation
Strong analytical thinking and the confidence to raise technical concerns proactively
Transparent written and verbal communica