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- Tasks: Manage regulatory data and submissions for global pharmaceutical operations.
- Company: Leading firm in the life sciences sector with a focus on innovation.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Join a dynamic team and make a significant impact in global regulatory compliance.
- Qualifications: 8-12 years in Regulatory Information Management with Ennov RIM expertise.
- Other info: Collaborative environment with a strong emphasis on career development.
The predicted salary is between 36000 - 60000 £ per year.
This role is for one of the Weekday's clients.
Min Experience: 8 years
Location: Europe
Job Type: full-time
We are seeking an experienced Senior Regulatory Information Management (RIM) Specialist with deep expertise in Ennov RIM to support global regulatory operations for pharmaceutical, biotechnology, or life sciences organizations. The ideal candidate will play a critical role in managing regulatory data, submissions, and dossiers across the product lifecycle while ensuring compliance with global health authority requirements. This role requires strong functional knowledge of regulatory processes, hands-on system expertise, and the ability to collaborate with cross-functional stakeholders.
Key Responsibilities:
- Act as a subject matter expert (SME) for Ennov RIM, supporting configuration, maintenance, and optimization of RIM modules including Registration, Dossier, Submission, and Lifecycle Management.
- Manage end-to-end regulatory information management processes, ensuring accuracy, completeness, and consistency of regulatory data across regions.
- Support global regulatory submissions and lifecycle activities including IND, NDA, BLA, MAA, variations, renewals, and post-approval changes.
- Ensure compliance with global regulatory standards and health authority requirements (FDA, EMA, MHRA, PMDA, and other regional agencies).
- Collaborate with Regulatory Affairs, Quality, IT, and external vendors to streamline RIM workflows and improve system usability.
- Drive data governance, master data management, and controlled vocabularies within Ennov RIM.
- Support system upgrades, validations, and enhancements in alignment with GxP and 21 CFR Part 11 requirements.
- Develop and maintain SOPs, work instructions, and training materials related to RIM processes and systems.
- Provide user support, troubleshooting, and training to ensure effective adoption and utilization of Ennov RIM.
- Participate in audits and inspections by ensuring system readiness, data traceability, and compliance documentation.
Required Skills & Experience:
- 8–12 years of experience in Regulatory Information Management within the pharmaceutical, biotech, or life sciences industry.
- Strong hands-on experience with Ennov RIM (mandatory), including regulatory data, submissions, and lifecycle management.
- In-depth understanding of global regulatory frameworks, submission standards (eCTD), and regulatory operations.
- Experience working in GxP-regulated environments with knowledge of validation and compliance requirements.
- Proven ability to manage complex regulatory data and multiple products across regions.
- Strong analytical, documentation, and problem-solving skills.
- Excellent communication and stakeholder management skills.
Preferred Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
- Experience supporting RIM system implementations, migrations, or integrations.
- Exposure to other RIM or regulatory systems is a plus.
Ennov RIM employer: Weekday AI
Contact Detail:
Weekday AI Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Ennov RIM
✨Network Like a Pro
Get out there and connect with folks in the industry! Attend conferences, webinars, or local meetups related to regulatory affairs. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Show Off Your Skills
When you get the chance to chat with potential employers, make sure to highlight your hands-on experience with Ennov RIM. Share specific examples of how you've managed regulatory data and submissions to demonstrate your expertise.
✨Tailor Your Approach
Before any interview, do your homework on the company and its regulatory processes. Tailor your responses to show how your experience aligns with their needs, especially in managing compliance with global health authority requirements.
✨Apply Through Us!
Don’t forget to check out our website for job listings that match your skills. Applying through us not only gives you access to exclusive opportunities but also helps us support you better in your job search journey!
We think you need these skills to ace Ennov RIM
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience with Ennov RIM and regulatory processes. We want to see how your skills match the job description, so don’t be shy about showcasing your relevant achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. We love seeing enthusiasm and a clear understanding of the responsibilities, so make it personal and engaging.
Showcase Your Expertise: Don’t forget to emphasise your hands-on experience with regulatory submissions and lifecycle management. We’re looking for someone who can hit the ground running, so let us know how you’ve tackled similar challenges in the past.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just follow the prompts!
How to prepare for a job interview at Weekday AI
✨Know Your Ennov RIM Inside Out
Make sure you have a solid grasp of Ennov RIM and its modules. Brush up on your knowledge of Registration, Dossier, Submission, and Lifecycle Management. Be ready to discuss how you've used these in past roles and how you can optimise them for the company.
✨Showcase Your Regulatory Expertise
Prepare to talk about your experience with global regulatory frameworks and submission standards like eCTD. Highlight specific examples where you've ensured compliance with health authority requirements, as this will demonstrate your capability to manage complex regulatory data.
✨Collaboration is Key
This role involves working with various stakeholders, so be ready to share examples of how you've successfully collaborated with teams like Regulatory Affairs, Quality, and IT. Discuss any challenges you faced and how you overcame them to streamline workflows.
✨Be Ready for Technical Questions
Expect some technical questions related to GxP regulations and validation processes. Brush up on 21 CFR Part 11 requirements and be prepared to explain how you've applied these in your previous roles. This will show that you're not just familiar with the theory but also the practical application.
