Analyst-Regulatory Information management
Analyst-Regulatory Information management
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Job Title: Analyst – Regulatory Information Management
Location: Marlow
Contract: 12 Months / Hybrid 3 days onsite
Hours: 37.5 hours per week
Job Description
SRG are looking for an analyst – regulatory information management for a leading pharmaceutical company based in Marlow. As part of this role, you will be supporting process improvement initiatives. Support structured data submissions and all related tasks, including xEVMPD, SPOR and IDMP implementation.
Support Regulatory Information Management (RIM) globally, focusing on key systems and processes, including COSMOS (RIM system) Supports Data enrichment and archiving remediation initiatives.
Work with members of the Regulatory Lifecycle Management team to share knowledge and improve RIM processes.
Build 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.
Duties and Responsibilities
* Subject to internal QC audit, ensure all data submissions and related reference/master data are managed accurately and in accordance with SOPs.
* Establish relationships with ‘in-country’ teams and global regulatory teams to ensure that they are aware of how data submissions are managed.
* Maintain awareness of International regulatory procedures and how any changes may impact reference and master data management 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 BTS to implement system upgrades and other improvements.
* Qualify requests and run accurate reports and queries as requested.
* Maintain compliance with departmental SOPs and Work Instructions.
Experience and Qualifications
* Graduate (preferably in a Life Science or IT related discipline), or equivalent/relevant experience.
* Knowledge of Regulatory Business Processes / Pharma and/or Medical Devices 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 EMA Platforms preferred (IDMP, XEVMPD, SPOR, CTIS, IRIS)
Essential Skills and Abilities
* 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, prioritize, and manage multiple projects and deadlines
* Sense of personal responsibility and accountability
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Contract
Job function
* Job function
Other
* Industries
Pharmaceutical Manufacturing
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