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 Hampshire, Portsmouth 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 meaningful contributions to global regulatory operations.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Associate - Regulatory Operations - Publishing in Hampshire, Portsmouth
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those who work at Freyr or similar companies. A friendly chat can open doors and give you insights that job postings just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA/EMA regulations and the specific tools mentioned in the job description. We want to see you shine with your expertise during those crucial conversations!
✨Tip Number 3
Showcase your skills! Bring examples of your past work in regulatory publishing to the table. Whether it's a project you led or a challenge you overcame, we love to see how you've made an impact.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. Plus, it shows you're serious about joining our team at Freyr.
We think you need these skills to ace Regulatory Affairs Associate - Regulatory Operations - Publishing in Hampshire, Portsmouth
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!
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 skills can benefit us at Freyr. Don't forget to mention your proficiency in Chinese, as it's a must-have for this role.
Showcase Relevant Experience:When detailing your experience, focus on your work with INDs, NDAs, and MAAs. We love seeing examples of your past projects, especially those that involved publishing deliverables or quality control. Make it clear how you’ve contributed to successful submissions!
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 shows you’re proactive and keen to join our team!
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 explain how you've used these tools in past roles to produce high-quality submissions.
✨Demonstrate Team Coordination
Since this role involves liaising with multidisciplinary teams, think of specific instances where you successfully coordinated with others. Highlight your communication skills and how you ensured everyone was on the same page.
✨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 discuss how you’ve handled similar tasks in previous positions.
