SRG are currently looking for Regulatory Submissions Analyst for a Global Pharmaceutical Company who have opened a vacancy in their Regulatory team.
SRG are currently looking for Regulatory Submissions Analyst for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 12 Month basis to be based at their offices in Buckinghamshire.The Role:
- Supports Regulatory Information Management (RIM) globally, focusing on key systems and processes, including COSMOS (RIM system) Supports Data and archiving remediation initiatives post COSMOS go live in March.Support process improvement initiatives, including data enrichment. Supports structured data submissions and all related tasks, including xEVMPD and IDMP implementation.
- Works with other members of the Regulatory Information Management team to share knowledge and improve RIM processes.
- Builds and maintains relationships with Regulatory and other staff within and outside of the region to ensure effective communication and efficient implementation of regulatory information management.
- Subject to internal QC audit, ensure all data relating to regulatory submissions, approvals, commitments and agency correspondence is managed within the global system COSMOS 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 within the Regulatory Information Management system.
- 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, subject to Global Data Council representations and approvals.
- 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 with departmental SOPs and Work Instructions.
- 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.
- Organisational and planning ability.
- Excellent written, verbal and interpersonal skills.
- Ability to work effectively and collaboratively across cultures and cross-functionally.
- Ability to identify compliance risks and escalate when necessary.
- Ability to multitask, prioritise, and manage multiple projects and deadlines.
- Sense of personal responsibility and accountability.
Carbon60, Lorien, SRG - the Impellam Group STEM Portfolio is acting as an Employment Business in relation to this vacancy.
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