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- Tasks: Lead regulatory strategy and manage submissions for clinical trials in a collaborative team.
- Company: Freyr is an innovative company providing regulatory solutions for the Life Sciences industry.
- Benefits: Join a dynamic work environment with opportunities for growth and impact in Warsaw, Poland.
- Why this job: Be part of shaping the future of regulatory services and make a real difference.
- Qualifications: Knowledge of EU Clinical Trial Regulation and experience with regulatory submissions required.
- Other info: This role is open to candidates in the EU/UK only.
The predicted salary is between 36000 - 60000 £ per year.
This role is open for candidates in EU/UK only. Applications from other locations will not be considered.
Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.
At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint to Warsaw, Poland, we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.
If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr's new chapter in Warsaw, Poland. Together, we can shape the future of regulatory solutions.
Please apply to this job post or you can visit our Careers page for more openings. Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!
Location: UKKey Skills: EU-CTR / CTIS.
Essential duties and responsibilities:
- Provide critical support in developing global regulatory strategy, planning and execution of global investigational submissions and manages 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, health authority queries, and regulatory obligations.
- Research and apply regulatory intelligence and knowledge of strategic options to effect innovative regulatory pathways and solutions to complex global requirements and regulatory challenges.
- Perform independent QC on prepared CTA submissions which include submission documents and structured data populated within the CTIS and IRAS submission portals.
- Act as a liaison while coordinating CTA activities with other multidisciplinary teams.
- Provide support for preparation, submission, lifecycle, and archival of CTA submissions and correspondences.
- Overall knowledge of regulation/guidance in support of EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019.
- Demonstrated performance in managing and producing time-intensive deliverables.
- Strong attention to detail in data entry accuracy and in following specific process steps within procedural documents.
- Knowledge of Document Management Systems (Documentum-based is preferred).
- Recent experience in submitting regulatory submissions using Health Authority Portals.
- Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint.
- Recent experience with regulatory applications such as CTAs is preferred.
Regulatory Affairs Manager - EU CTR employer: Freyr Solutions
Contact Detail:
Freyr Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager - EU CTR
✨Tip Number 1
Familiarise yourself with the EU Clinical Trial Regulation (CTR) and the UK Medicines for Human Use regulations. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with EU-CTR and CTIS. Engaging with industry experts can provide valuable insights and may even lead to referrals.
✨Tip Number 3
Stay updated on recent changes in regulatory guidelines and health authority portals. Being knowledgeable about current trends and updates will set you apart as a candidate who is proactive and well-informed.
✨Tip Number 4
Prepare to discuss specific examples of your past experiences with regulatory submissions and lifecycle management. Highlighting your hands-on experience will showcase your capability to handle the responsibilities of the Regulatory Affairs Manager role.
We think you need these skills to ace Regulatory Affairs Manager - EU CTR
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Regulatory Affairs Manager position. Familiarise yourself with EU Clinical Trial Regulation (CTR) and UK regulations to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience with regulatory submissions, particularly in relation to EU-CTR and CTAs. Use specific examples to demonstrate your expertise and how it aligns with the role at Freyr.
Showcase Your Skills: Make sure to highlight your attention to detail, ability to manage time-intensive deliverables, and proficiency with document management systems. Mention any relevant software skills, especially with Microsoft Office and Health Authority Portals.
Craft a Compelling Cover Letter: Write a tailored cover letter that reflects your passion for regulatory affairs and your desire to contribute to Freyr's mission. Discuss how your background and skills can help shape the future of regulatory solutions at their new Warsaw location.
How to prepare for a job interview at Freyr Solutions
✨Understand the Regulatory Landscape
Familiarise yourself with the EU Clinical Trial Regulation and UK Medicines regulations. Being able to discuss these regulations confidently will show your expertise and commitment to the role.
✨Showcase Your Collaborative Skills
Since the role involves working with various teams, prepare examples of how you've successfully collaborated in the past. Highlight your ability to communicate effectively with multidisciplinary teams.
✨Demonstrate Attention to Detail
Prepare to discuss specific instances where your attention to detail made a difference in your work. This could involve quality control processes or ensuring compliance with regulatory submissions.
✨Be Ready for Scenario-Based Questions
Expect questions that assess your problem-solving skills in regulatory challenges. Think of scenarios where you had to navigate complex regulatory pathways and be ready to explain your thought process.
