At a Glance
- Tasks: Produce regulatory publishing deliverables and ensure submission readiness.
- Company: Freyr, a global leader in Regulatory Solutions for Life Sciences.
- Benefits: Competitive salary, career growth, and a dynamic work environment.
- Other info: Collaborative culture with opportunities to work on innovative projects.
- Why this job: Join a team that shapes the future of healthcare through regulatory excellence.
- Qualifications: 2-5 years in Regulatory Affairs and proficiency in Chinese required.
The predicted salary is between 36000 - 60000 £ per year.
About Freyr
Freyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise.
Location: United Kingdom
Experience: 2 to 5 years in Regulatory Affairs. Proficiency in Chinese Language is mandatory for this role.
Description
- Produce regulatory publishing deliverables (e.g., INDs, NDAs, NDSs, MAAs, annual reports, routine submissions, Clinical Study Reports) in accordance with US and global requirements, using electronic publishing tools, and an EDMS system.
- Perform independent publishing QC on published output, complete appropriate checklists and/or provide assessments for the activities around the quality of document-level publishing and submission readiness of source documents for submission-level publishing.
- Act as a liaison while coordinating regulatory publishing activities with other multidisciplinary teams.
- Provide expertise on regulatory publishing and authoring activities.
- Provide support for preparation, submission, tracking, and archival of electronic and paper submissions.
- Assist with development of assigned regulatory operations work instructions.
- Perform User Acceptance Testing (UAT) for publishing tools, as required.
- Participate in new technology evaluation for regulatory publishing needs.
- Stay abreast with updates for regulatory and/or industry standards.
Required Competencies
- Overall knowledge of FDA/EMA/HC/SwissMedic/TGA/MHRA/MedSafe/NMPA regulations/guidance and industry standards for electronic and paper submissions.
- Strong background in regulatory operations, including formatting, publishing, submitting, life-cycling, and archiving sequences.
- Demonstrated performance in managing and producing time-intensive deliverables.
- Knowledge of Document Management Systems (Documentum-based is preferred) and publishing tools (e.g., Lorenz docuBridge, InSight Publisher, Lorenz eValidator, GlobalSubmit Validate, GlobalSubmit Review, and ISI Toolbox).
- Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint.
- Recent experience with NDAs / MAAs/ NDSs and document level publishing is essential.
Locations
Regulatory Affairs Associate - Regulatory Operations - Publishing in Cheshire, Warrington employer: Freyr Solutions
Freyr is an exceptional employer that fosters a collaborative and innovative work culture, making it an ideal place for Regulatory Affairs Associates to thrive. With a strong commitment to employee growth, Freyr offers extensive training opportunities and the chance to work alongside industry leaders in the heart of the United Kingdom's vibrant life sciences sector. Employees benefit from a supportive environment that values precision and expertise, ensuring that every team member can contribute meaningfully to impactful regulatory solutions.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Associate - Regulatory Operations - Publishing in Cheshire, Warrington
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and role thoroughly. Understand their regulatory processes and be ready to discuss how your experience aligns with their needs. We want you to shine!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources to get comfortable with common questions. The more you practice, the more confident you'll feel when it counts.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Affairs Associate - Regulatory Operations - Publishing in Cheshire, Warrington
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Regulatory Affairs Associate. Highlight your experience in regulatory operations and any specific tools you've used, like Documentum or Lorenz. We want to see how your background aligns with what we're looking for!
Showcase Your Skills:Don’t just list your skills; demonstrate them! Use examples from your past work to show how you’ve managed time-intensive deliverables or performed quality checks on publishing outputs. This helps us see your practical experience in action.
Be Clear and Concise:When writing your application, clarity is key. Use straightforward language and keep your sentences concise. We appreciate a well-structured application that gets straight to the point without unnecessary fluff.
Apply Through Our Website:We encourage you to apply through our website for the best chance of being noticed. It’s super easy, and it ensures your application goes directly to us. Plus, we love seeing candidates who take that extra step!
How to prepare for a job interview at Freyr Solutions
✨Know Your Regulations
Make sure you brush up on the latest FDA, EMA, and other relevant regulations. Being able to discuss these confidently will show that you’re not just familiar with the basics but are also up-to-date with current standards.
✨Showcase Your Publishing Skills
Prepare examples of your experience with regulatory publishing tools like Lorenz docuBridge or GlobalSubmit. Be ready to discuss specific projects where you produced deliverables like INDs or NDAs, highlighting your role and the outcomes.
✨Demonstrate Team Coordination
Since this role involves liaising with multidisciplinary teams, think of instances where you successfully coordinated activities. Share how you managed communication and ensured everyone was on the same page during a project.
✨Prepare for Technical Questions
Expect questions about User Acceptance Testing (UAT) and Document Management Systems. Brush up on your technical knowledge and be prepared to explain how you’ve used these systems in past roles to enhance your credibility.
