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- 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.
- 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.
- Other info: Collaborative culture with opportunities to work on innovative projects.
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.
Regulatory Affairs Associate - Regulatory Operations - Publishing in Glasgow employer: Freyr Solutions
Contact Detail:
Freyr Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Associate - Regulatory Operations - Publishing in Glasgow
✨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. Show them you’re not just another candidate!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources to refine your answers. Focus on articulating your experience with regulatory publishing and how you can contribute to their team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take that extra step to engage with us directly.
We think you need these skills to ace Regulatory Affairs Associate - Regulatory Operations - Publishing in Glasgow
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Associate role. Highlight your experience in regulatory operations and any relevant publishing tools you've used. We want to see how your skills match 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 affairs and how your background makes you a great fit for our team. Keep it concise but engaging – we love a good story!
Showcase Your Technical Skills: Don’t forget to mention your proficiency with electronic publishing tools and Document Management Systems. We’re keen on candidates who can hit the ground running, so let us know what you’ve worked with before!
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 a few clicks and you’re done!
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 genuinely engaged with the field.
✨Showcase Your Publishing Skills
Prepare examples of your experience with regulatory publishing deliverables. Be ready to discuss specific tools you've used, like Lorenz docuBridge or Documentum, and how you’ve ensured submission readiness in past roles.
✨Demonstrate Team Coordination
Since this role involves liaising with multidisciplinary teams, think of instances where you successfully coordinated with others. Highlight your communication skills and how you’ve managed to keep everyone on the same page during projects.
✨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 contributed to technology evaluations in your previous roles.