Analyst, Regulatory Information Management

SRG are currently looking for a Regulatory Information Analyst for a Global Pharmaceutical Company who have opened a new vacancy within their team on an initial 12 Month basis to be based at their office in Maidenhead.

The Role:

This role supports Regulatory Information Management (RIM) globally, focusing on key systems and processes.

Supporting process improvement initiatives, including data enrichment. Supports structured data submissions and all related tasks, including xEVMPD and IDMP implementation.

Working with other members of the Regulatory Information Management team to share knowledge and improve RIM processes.

Building and maintaining relationships with Regulatory and other staff within and outside of the region to ensure effective communication and efficient implementation of Regulatory Information Management.

Key Responsibilities:

• Subject to internal QC audit, ensure all data relating to regulatory submissions, approvals, commitments and agency correspondence is managed within the global system accurately and in accordance with SOPs.
• Establish relationships with 'in-country' teams and global regulatory teams to ensure that they are aware of how Regulatory Information is managed.
• Maintain awareness of International regulatory procedures and how any changes may impact maintenance of data.
• Work with other Local System Administrators to suggest, discuss and implement system and process improvements in line with regulatory changes and as part of a quality management cycle.
• Work with global RD-IT to implement system upgrades and other improvements, including system testing and user training as needed.
• Qualify requests and run accurate reports and queries as requested.
• Maintain compliance.

Skills/Experience Required:

• Graduate (preferably in a Life Science or IT related discipline), or equivalent/relevant experience.
• Knowledge of Regulatory Business Processes / Pharma R&D Business
• Regulatory Systems and Database experience (Liquent, Veeva, CARA or similar)
• Some knowledge of European Regulatory Procedures (Centralised, Decentralised and Mutual Recognition)
• Some knowledge of Regulatory Submission types (MAAs, Variations, Renewals, CTAs, DSURs etc)
• Knowledge of IDMP, XEVMPD, SPOR, CTIS

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