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- Tasks: Support regulatory data submissions and process improvements in a leading pharmaceutical company.
- Company: Join a top-tier pharmaceutical firm based in Marlow, known for innovation and excellence.
- Benefits: Enjoy a hybrid work model with 3 days onsite and competitive pay of £23 per hour.
- Why this job: Be part of impactful projects that enhance global regulatory processes and improve healthcare outcomes.
- Qualifications: Ideal for graduates in Life Sciences or IT, with knowledge of regulatory systems and processes.
- Other info: This is a 12-month contract role, perfect for gaining valuable industry experience.
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.
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Analyst - Regulatory Information management employer: SRG
Contact Detail:
SRG Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Analyst - Regulatory Information management
✨Tip Number 1
Familiarise yourself with the key regulatory systems mentioned in the job description, such as COSMOS and EMA platforms like IDMP and xEVMPD. Understanding these systems will not only help you during the interview but also demonstrate your proactive approach to the role.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who work in Regulatory Information Management. Engaging with them on platforms like LinkedIn can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Stay updated on the latest changes in European regulatory procedures and submission types. This knowledge will show your commitment to the field and your ability to adapt to evolving regulations, which is crucial for this position.
✨Tip Number 4
Prepare to discuss specific examples of how you've contributed to process improvements or data management in previous roles. Highlighting your experience in these areas will align well with the responsibilities outlined in the job description.
We think you need these skills to ace Analyst - Regulatory Information management
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory information management and any specific knowledge of systems like COSMOS, Liquent, or Veeva. Use keywords from the job description to align your skills with what the company is looking for.
Craft a Strong Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention your understanding of regulatory processes and how your background in life sciences or IT makes you a suitable candidate for this position.
Showcase Relevant Skills: Emphasise your organisational and planning abilities, as well as your excellent written and verbal communication skills. Provide examples of how you've successfully managed multiple projects or collaborated across teams in previous roles.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a role that involves compliance and data management.
How to prepare for a job interview at SRG
✨Understand Regulatory Information Management
Make sure you have a solid grasp of what Regulatory Information Management (RIM) entails. Familiarise yourself with key systems like COSMOS and the various regulatory submission types such as MAAs and Variations. This knowledge will help you demonstrate your expertise during the interview.
✨Showcase Your Organisational Skills
Since the role requires excellent organisational and planning abilities, be prepared to discuss specific examples from your past experiences where you successfully managed multiple projects or deadlines. Highlight how you prioritised tasks and ensured compliance with SOPs.
✨Emphasise Communication Skills
Effective communication is crucial in this role. Be ready to share instances where you built relationships with cross-functional teams or 'in-country' teams. Discuss how you facilitated knowledge sharing and improved processes through collaboration.
✨Stay Updated on Regulatory Changes
Demonstrate your awareness of international regulatory procedures and any recent changes that could impact RIM. Showing that you keep up with industry trends will reflect your commitment to the field and your ability to adapt to new challenges.
