Analyst - Regulatory Information management

SRG; Marlow; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in Marlow is seeking an Analyst for Regulatory Information Management to support process improvement initiatives and ensure accurate data submissions. The ideal candidate will have a degree in Life Sciences or a related field and experience with regulatory systems. This is a hybrid role requiring 3 days onsite work.

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.
• Some knowledge of European Regulatory Procedures.
• Some knowledge of Regulatory Submission types.
• Knowledge of EMA Platforms preferred.

Responsibilities

• Ensure all data submissions are managed accurately.
• Establish relationships with 'in-country' and global regulatory teams.
• Maintain awareness of International regulatory procedures.
• Implement system upgrades and process improvements.
• Run accurate reports and queries as requested.

Skills

Organisational and planning ability

Excellent written, verbal and interpersonal skills

Ability to work effectively and collaboratively across cultures

Ability to identify compliance risks

Ability to multitask

Education

Graduate in Life Science or IT related discipline

Tools

Regulatory Systems and Database (Liquent, Veeva, CARA)

Job description

Job Title: Analyst - Regulatory Information Management

Location: Marlow

Contract: 12 Months / Hybrid 3 days onsite

Hours: 37.5 hours per week

Rates: 23 p/h

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

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