At a Glance
- Tasks: Lead global regulatory strategies and manage complex submissions for clinical trials.
- Company: Freyr, a global leader in Regulatory Solutions for Life Sciences.
- Benefits: Remote work, collaborative culture, and opportunities for professional growth.
- Other info: Join a dynamic team and work on innovative projects across global markets.
- Why this job: Make a real impact on patient safety and global transparency in healthcare.
- Qualifications: Experience in regulatory submissions and strong attention to detail.
The predicted salary is between 60000 - 80000 € 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.
Freyr's client is seeking a Regulatory Affairs Manager to fill a critical role in supporting development and execution of global regulatory strategies for investigational submissions, with a focus on EU and UK CTR. This role ensures compliance with regulatory requirements and manages lifecycle activities in alignment with the Global Regulatory Lead (GRL).
Location: Remote (United Kingdom)
Job Type: Permanent/Full-Time
- Provide critical support in developing global regulatory strategy, planning, and execution of global investigational submissions, and manage lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).
- Work collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans, address global regulatory issues, respond to health authority queries, and meet regulatory obligations.
- Research and apply regulatory intelligence and knowledge of strategic options to enable innovative regulatory pathways and solutions for complex global requirements and regulatory challenges.
- Perform independent QC on prepared CTA submissions, including submission documents and structured data populated within the CTIS and IRAS submission portals.
- Assist with the development of assigned regulatory operations work instructions.
- Stay current with updates to regulatory and industry standards.
- Demonstrated performance in managing and producing time-intensive deliverables.
- Strong attention to detail in data entry accuracy and in following specific process steps outlined in procedural documents.
- Recent experience submitting regulatory submissions using Health Authority Portals.
- Strong computer skills with proven experience in Microsoft Office (Word, Excel, Access, PowerPoint) and SharePoint.
- Recent CTA Regulatory application experience is essential.
Joining Freyr gives you the platform to work on impactful regulatory initiatives across global markets. You will collaborate with experienced regulatory leaders, gain exposure to complex submissions, and contribute to meaningful projects supporting patient safety and global transparency. Opportunity to work within a collaborative and growth-driven global regulatory team, cross-functionally supporting innovative clinical trials.
Lead complex CTA submissions while shaping regulatory strategies aligned with EMA, MHRA, and ICH guidelines.
Senior Manager/Director of Regulatory Affairs in Nottingham employer: Freyr Solutions
Freyr is an exceptional employer that offers a dynamic and collaborative work environment, allowing employees to engage in impactful regulatory initiatives across global markets. With a strong focus on employee growth, Freyr provides opportunities to work alongside experienced regulatory leaders, enhancing skills through exposure to complex submissions and innovative clinical trials. The remote working arrangement in the UK further supports a healthy work-life balance, making it an attractive choice for professionals seeking meaningful and rewarding careers in regulatory affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager/Director of Regulatory Affairs in Nottingham
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU and UK CTR regulations. We recommend practising common interview questions and having examples ready that showcase your experience with regulatory submissions.
✨Tip Number 3
Don’t just apply and wait! Follow up on your applications after a week or so. A quick email expressing your continued interest can set you apart from other candidates. We love seeing proactive candidates!
✨Tip Number 4
Check out our website for the latest job openings. We regularly update our listings, and applying directly through us can give you an edge. Plus, it’s super easy to navigate!
We think you need these skills to ace Senior Manager/Director of Regulatory Affairs in Nottingham
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Regulatory Affairs Manager. Highlight your experience with global regulatory strategies and any specific knowledge of EU and UK CTR. 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 contribute to our team at Freyr. Be sure to mention any relevant experience with Health Authority Portals.
Showcase Your Attention to Detail:In regulatory affairs, attention to detail is key. When filling out your application, double-check for any typos or errors. We appreciate candidates who take the time to ensure their submissions are accurate and polished.
Apply Through Our Website:We encourage you to apply directly through our website. This way, we can easily track your application and ensure it gets the attention it deserves. Plus, it’s the best way to stay updated on your application status!
How to prepare for a job interview at Freyr Solutions
✨Know Your Regulatory Stuff
Make sure you brush up on the latest EU and UK Clinical Trial Regulations (CTR). Familiarise yourself with recent changes and how they impact investigational submissions. Being able to discuss these confidently will show that you're not just knowledgeable but also proactive in staying updated.
✨Showcase Your Collaboration Skills
Since this role involves working closely with various teams, be ready to share examples of how you've successfully collaborated in the past. Highlight specific projects where you worked with cross-functional teams, and explain how your contributions helped achieve regulatory goals.
✨Demonstrate Attention to Detail
Prepare to discuss your approach to quality control and data accuracy. Bring examples of how you've ensured precision in your previous submissions, especially when using Health Authority Portals. This will underline your commitment to compliance and thoroughness.
✨Be Ready for Scenario Questions
Expect questions that put you in hypothetical situations related to regulatory challenges. Think about how you would handle complex submissions or respond to health authority queries. Practising these scenarios can help you articulate your thought process and problem-solving skills effectively.
