At a Glance
- Tasks: Manage regulatory data and documents for global submissions in a dynamic environment.
- Company: Join Freyr, a fast-growing innovator in regulatory solutions for Life Sciences.
- Benefits: Remote work, collaborative culture, and opportunities for professional growth.
- Why this job: Make a real impact in shaping the future of regulatory services.
- Qualifications: 7-9 years in regulatory management with expertise in Veeva Vault.
- Other info: Be part of an exciting journey as we expand our footprint in the industry.
The predicted salary is between 36000 - 60000 Β£ per year.
Overview
Freyr Solutions is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. We assist pharmaceutical, medical device, and biotech companies in navigating regulatory compliance.
Join Freyr to collaborate in a dynamic work environment that empowers the team to make a real impact as we expand our footprint.
Position
Position Title: Manager β Regulatory Information Management (RIM)
Location: Remote (Base location should be UK / Poland). Not for candidates in India.
Job Summary
We are seeking a Senior Regulatory Management Professional with 7β9 years of hands-on experience in managing regulatory data and documents for global submissions. The ideal candidate will have 6+ years of expertise in regulatory data and document management within the Pharmaceutical Regulatory Information Management (RIM) domain. This role requires close collaboration with cross-functional stakeholders to ensure accurate document management, maintain links with registration data in the RIM database, identify process gaps, support lifecycle management, and enhance data-driven decision-making.
Key Responsibilities
- Manage submission dossiers, including document classification and application of appropriate metadata.
- Oversee regulatory product lifecycle management using Veeva Vault.
- Translate Health Authority (HA) requirements into database specifications.
- Collaborate with internal teams and external partners during data/document migration activities.
Required Skills & Experience
- 6-8 years experience in Pharma Regulatory Operations with Documents/submission management in Veeva Vault RIM system.
- Hands-on experience with Veeva Vault, specifically in Dossier Management, including document upload, metadata assignment, and lifecycle tracking.
- Strong understanding of document classification and metadata management to support accurate retrieval and compliance.
- Proficiency in regulatory data and document systems within RIM frameworks.
- Solid project management skills with a proven ability to work in cross-functional, collaborative team environments.
- Self-motivated, detail-oriented, and able to independently investigate and resolve complex data or process issues.
Preferred Qualifications
- Doct./Master in Pharma/Biological Sciences.
- Veeva Vault Certification (good to have).
- Experience working in JIRA/SharePoint/SNOW.
Industry Experience
- Experience with Veeva Vault application.
- Experience in Regulatory Ops. & Product Lifecycle management.
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Other
Industries
- Pharmaceutical Manufacturing
#J-18808-Ljbffr
Manager - Regulatory Information Management (RIM) employer: Freyr Solutions
Contact Detail:
Freyr Solutions Recruiting Team
StudySmarter Expert Advice π€«
We think this is how you could land Manager - Regulatory Information Management (RIM)
β¨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory field and let them know you're on the lookout for opportunities. A friendly chat can lead to insider info about openings at Freyr or even a referral!
β¨Tip Number 2
Prepare for interviews by researching Freyr's recent projects and innovations. Show us that youβre not just another candidate; demonstrate your passion for regulatory excellence and how you can contribute to our mission.
β¨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers, especially around your experience with Veeva Vault and regulatory data management. Confidence is key!
β¨Tip Number 4
Donβt forget to apply through our website! Itβs the best way to ensure your application gets noticed. Plus, it shows us youβre genuinely interested in joining the Freyr team. Letβs shape the future of regulatory solutions together!
We think you need these skills to ace Manager - Regulatory Information Management (RIM)
Some tips for your application π«‘
Tailor Your CV: Make sure your CV is tailored to the role of Manager - Regulatory Information Management. Highlight your experience in regulatory data and document management, especially with Veeva Vault, to show us youβre the perfect fit!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why youβre passionate about regulatory solutions and how your skills align with our mission at Freyr. Keep it engaging and personal!
Showcase Your Experience: When detailing your experience, focus on specific achievements in regulatory operations and project management. We want to see how youβve made an impact in previous roles, so donβt hold back!
Apply Through Our Website: We encourage you to apply through our Careers page for a smoother application process. Itβs the best way to ensure your application gets into our hands quickly, so donβt miss out!
How to prepare for a job interview at Freyr Solutions
β¨Know Your RIM Inside Out
Make sure you brush up on your knowledge of Regulatory Information Management, especially in relation to Veeva Vault. Be prepared to discuss your hands-on experience with document management and how you've tackled challenges in the past.
β¨Showcase Your Collaboration Skills
Since this role involves working closely with cross-functional teams, think of examples where you've successfully collaborated with others. Highlight how youβve managed stakeholder expectations and resolved conflicts to achieve common goals.
β¨Prepare for Technical Questions
Expect questions that dive deep into your technical expertise, particularly around document classification and metadata management. Brush up on the specifics of how youβve applied these skills in previous roles, and be ready to explain your thought process.
β¨Demonstrate Your Problem-Solving Abilities
Be ready to discuss complex data or process issues you've encountered and how you resolved them. Use the STAR method (Situation, Task, Action, Result) to structure your answers and clearly illustrate your problem-solving approach.