Analyst, Regulatory Information Management

5 days ago

Maidenhead, United Kingdom SRG Full time

Analyst, Regulatory Information Management

Department: Regulatory Affairs
Location: Maidenhead/Remote (hybrid)
Employment Type: Temporary - 12 month initial
Rate: circa £23 per hour (PAYE)

Role Summary

We are seeking a Regulatory Information Management (RIM) Analyst to support global RIM systems and processes for a leading global pharmaceutical company. This role is an initial 12 month contract and will involve managing data remediation, structured data submissions (xEVMPD, IDMP), and driving process improvements. You will collaborate with global regulatory teams, lead small-scale initiatives, and mentor junior colleagues to ensure compliance and efficiency in regulatory information management.

Key Responsibilities

Maintain compliance with SOPs and work instructions for COSMOS data management and submissions.
Lead small-scale system/process improvement projects and act as a point of contact for technical queries.
Support xEVMPD/IDMP data submissions and SPOR maintenance to meet regulatory requirements.
Resolve moderate data or archiving issues independently and recommend solutions.
Collaborate with global regulatory teams to ensure effective communication and implementation of RIM processes.
Participate in projects for data submission standards (e.g., IDMP, PQ CMC, SPQS).Experience & Skills Required

Graduate in a Life Sciences or IT discipline (and/or equivalent experience)
1-2 years of hands-on experience with RIM or regulatory systems.
Knowledge of regulatory business processes and European regulatory procedures.
Experience as a super user or trainer on major systems or structured data topics (xEVMPD/IDMP).
Strong organizational, communication, and interpersonal skills.
Ability to lead small team discussions and manage competing deadlines effectively.To Apply

If you are interested and want to find out more about this role, please click to apply or contact Theo Charles to discuss further.

Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy

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