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- Tasks: Support regulatory systems and processes while enhancing data management and compliance.
- Company: Join a leading global organisation in the pharmaceutical sector.
- Benefits: Competitive hourly rate, contract role with potential for growth.
- Why this job: Make an impact on regulatory operations and evolve structured data standards.
- Qualifications: Graduate degree or relevant experience in Life Sciences or IT preferred.
- Other info: Collaborative environment with opportunities to mentor and lead initiatives.
The predicted salary is between 20 - 24 £ per hour.
A leading global organisation is seeking a Regulatory Information Management (RIM) Analyst to support the effective management of regulatory systems, processes, and structured data. This role will focus heavily on COSMOS (RIM system), data remediation, archiving activities, and supporting global initiatives related to xEVMPD and IDMP implementation. The successful candidate will contribute to process improvement, data enrichment, and system optimisation, while also mentoring junior team members and collaborating with global Regulatory and cross-functional teams. This is an excellent opportunity for someone looking to grow within Regulatory Operations and support the evolution of structured data standards and RIM best practices.
Key Responsibilities
- Maintain compliance with departmental SOPs and Work Instructions related to COSMOS data management and submission requirements.
- Collaborate with RIM team members to propose, discuss, and implement system and process improvements.
- Lead small-scale process/system enhancement initiatives and act as a point of contact for technical and procedural questions within the team.
- Independently investigate and resolve moderate data or archiving issues, escalating when necessary.
- Support vocabulary maintenance within COSMOS aligned to Data Governance principles and Ontology tools.
- Support structured data submissions, including xEVMPD and IDMP, and maintain SPOR data.
- Participate in global project teams focused on implementing data submission standards (IDMP, PQ CMC, SPQS).
- Build strong relationships with affiliates and global regulatory teams to align on regulatory information management processes.
- Monitor evolving regulatory procedures and assess impacts on RIM data management.
Education & Experience
- Graduate degree (Life Sciences or IT preferred) or equivalent relevant experience.
- 1–2 years’ experience working with RIM systems or other regulatory platforms.
- Experience as a system super‑user, trainer, or SME in structured data topics such as xEVMPD or IDMP.
- Understanding of Regulatory and R&D business processes.
- Basic knowledge of EU regulatory procedures (Centralised, Decentralised, MRP).
- Familiarity with regulatory submission types (MAAs, Variations, Renewals, CTAs, DSURs, etc.).
- Strong organisational and planning capabilities.
- Excellent written, verbal, and interpersonal communication.
- Ability to lead small group discussions, workshops, or training sessions.
- Strong collaboration skills across cultures and cross‑functional teams.
- Advanced troubleshooting and proactive issue‑resolution abilities.
- Ability to manage and prioritise workloads across multiple small‑scale projects.
- High level of personal accountability and responsibility.
Seniority Level: Associate
Employment Type: Contract
Job Function: Other Pharmaceutical Manufacturing
Regulatory Specialist in Maidenhead employer: SRG
Contact Detail:
SRG Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Specialist in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its regulatory processes. Show them you’re not just another candidate; demonstrate your knowledge about their systems like COSMOS and how you can contribute to their goals.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to data management and process improvement. We want you to feel confident and ready to showcase your skills!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Specialist in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Specialist role. Highlight your experience with RIM systems, data management, and any relevant projects you've worked on. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory operations and how you can contribute to our team. Don't forget to mention any specific experiences that relate to COSMOS or structured data.
Showcase Your Communication Skills: Since this role involves collaboration with global teams, it's important to demonstrate your excellent written and verbal communication skills. Use clear and concise language in your application to show us you can communicate effectively.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Plus, it’s super easy!
How to prepare for a job interview at SRG
✨Know Your RIM Systems
Make sure you brush up on your knowledge of Regulatory Information Management systems, especially COSMOS. Be ready to discuss your experience with data management and how you've contributed to process improvements in previous roles.
✨Showcase Your Collaboration Skills
This role involves working closely with global teams, so be prepared to share examples of how you've successfully collaborated across cultures and functions. Highlight any experiences where you led discussions or training sessions.
✨Demonstrate Problem-Solving Abilities
Expect questions about how you've tackled data or archiving issues in the past. Prepare specific examples that showcase your troubleshooting skills and your proactive approach to resolving challenges.
✨Stay Updated on Regulatory Changes
Familiarise yourself with the latest developments in EU regulatory procedures and structured data standards like IDMP and xEVMPD. Showing that you're informed about current trends will demonstrate your commitment to the field.
