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- Tasks: Produce regulatory publishing deliverables and ensure quality for submissions.
- Company: Freyr, a global leader in Regulatory Solutions for Life Sciences.
- Benefits: Competitive salary, professional growth, and a dynamic work environment.
- Other info: Collaborative culture with opportunities to work on innovative projects.
- Why this job: Join a team making a real impact in the life sciences industry.
- Qualifications: 2-5 years in Regulatory Affairs and proficiency in Chinese required.
The predicted salary is between 30000 - 50000 £ 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.
Experience: 2 to 5 years in Regulatory Affairs. Proficiency in Chinese Language is mandatory for this role.
Publishing Resources:
- 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.
- 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.
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., 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 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
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those already working in regulatory affairs. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Show off your skills! When you get the chance to meet potential employers, whether at a networking event or an interview, be ready to discuss your experience with publishing deliverables and regulatory operations. Make it clear how your background aligns with their needs.
✨Tip Number 3
Don’t forget to follow up! After any interaction, drop a quick thank-you email. It keeps you on their radar and shows your enthusiasm for the role. Plus, it’s a great way to reiterate your interest in the position.
✨Tip Number 4
Apply through our website! We love seeing applications come directly from candidates who are genuinely interested in joining us. It shows initiative and gives you a better chance of standing out in the crowd.
We think you need these skills to ace Regulatory Affairs Associate - Regulatory Operations - Publishing
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 publishing and any relevant tools you've used. We want to see how your background aligns with what we're looking for!
Showcase Your Skills: Don’t forget to showcase your skills in document management systems and electronic publishing tools. If you’ve got experience with Documentum or similar, let us know! We love seeing candidates who can hit the ground running.
Be Clear and Concise: When writing your application, keep it clear and concise. Use bullet points where possible to make it easy for us to read. We appreciate a well-structured application that gets straight to the point!
Apply Through Our Website: Finally, make sure to apply through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at Freyr Solutions
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially around publishing deliverables like INDs and NDAs. Familiarise yourself with the latest industry standards and regulations, as this will show that you're proactive and well-informed.
✨Show Off Your Tech Skills
Since the role requires proficiency in various publishing tools and Document Management Systems, be ready to discuss your experience with these technologies. Bring examples of how you've used them in past roles, particularly in relation to QC and submission readiness.
✨Demonstrate Team Coordination
This position involves liaising with multidisciplinary teams, so think of examples where you've successfully coordinated projects or collaborated with others. Highlight your communication skills and how you ensure everyone is on the same page during regulatory publishing activities.
✨Prepare for Language Proficiency
As proficiency in Chinese is mandatory, be prepared to demonstrate your language skills during the interview. You might be asked to discuss regulatory concepts in Chinese, so practice articulating your thoughts clearly in both English and Chinese.