Regulatory Specialist

1 day ago

Maidenhead Berkshire, United Kingdom SRG Full time

Regulatory Information Management Analyst Location: Maidenhead (Hybrid) Contract: 12 Months Rate: £20–£24 per hour (based on experience) A leading global organisation is seeking a Regulatory Information Management (RIM) Analyst to support the effective management of regulatory systems, processes, and structured data. This role will focus heavily on COSMOS (RIM system), data remediation, archiving activities, and supporting global initiatives related to xEVMPD and IDMP implementation. The successful candidate will contribute to process improvement, data enrichment, and system optimisation, while also mentoring junior team members and collaborating with global Regulatory and cross-functional teams. This is an excellent opportunity for someone looking to grow within Regulatory Operations and support the evolution of structured data standards and RIM best practices. Key Responsibilities Maintain compliance with departmental SOPs and Work Instructions related to COSMOS data management and submission requirements. Collaborate with RIM team members to propose, discuss, and implement system and process improvements. Lead small-scale process/system enhancement initiatives and act as a point of contact for technical and procedural questions within the team. Independently investigate and resolve moderate data or archiving issues, escalating when necessary. Support vocabulary maintenance within COSMOS aligned to Data Governance principles and Ontology tools. Support structured data submissions, including xEVMPD and IDMP, and maintain SPOR data. Participate in global project teams focused on implementing data submission standards (IDMP, PQ CMC, SPQS). Build strong relationships with affiliates and global regulatory teams to align on regulatory information management processes. Monitor evolving regulatory procedures and assess impacts on RIM data management. Minimum Requirements Education & Experience Graduate degree (Life Sciences or IT preferred) or equivalent relevant experience. 1–2 years’ experience working with RIM systems or other regulatory platforms. Experience as a system super-user, trainer, or SME in structured data topics such as xEVMPD or IDMP. Understanding of Regulatory and R&D business processes. Basic knowledge of EU regulatory procedures (Centralised, Decentralised, MRP). Familiarity with regulatory submission types (MAAs, Variations, Renewals, CTAs, DSURs, etc.). Essential Skills & Abilities Strong organisational and planning capabilities. Excellent written, verbal, and interpersonal communication. Ability to lead small group discussions, workshops, or training sessions. Strong collaboration skills across cultures and cross-functional teams. Advanced troubleshooting and proactive issue-resolution abilities. Ability to manage and prioritise workloads across multiple small-scale projects. High level of personal accountability and responsibility.

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