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For Companies At a Glance
- Tasks: Lead regulatory management for clinical studies and train junior staff.
- Company: Join Ergomed, a global CRO with a passion for improving patients' lives.
- Benefits: Competitive salary, great benefits, and opportunities for career progression.
- Why this job: Work on diverse projects and have your achievements recognised in a supportive environment.
- Qualifications: Experience in regulatory affairs and a science-based degree required.
- Other info: Flexible work options available; join a small, dynamic team.
The predicted salary is between 36000 - 60000 £ per year.
Regulatory Affairs Manager
We offer an opportunity to learn, progress and achieve, in a dynamic growing environment.
The Company
We are a growing international full service CRO company with an HQ in Guildford UK and major sites across the globe that offers its employees a genuine opportunity to develop, varied and interesting challenges, and recognition for achievement.
Ergomed established in 1997 by two physicians in Croatia, provides expertise in drug development. Since this beginning, the company has grown to employ 700 people worldwide including its division of PrimeVigilance and is listed on the LSE. Our clients value us for our scientific and medical expertise and we have one of the highest client retention rates in the industry.
Our innovative site management and study physician model set us apart from our competitors.
Helping to develop drugs that improve patient\’s lives is our passion.
The Position
We are looking for a Regulatory Affairs Manager, to be based in UK, Germany, Poland, Croatia office or home based.
- We offer the chance to work in a small but growing team of around 8 people in a wide range of projects and therapy areas, and across all phases.
- We offer a friendly professional working environment.
- We offer a competitive salary plus a good benefits package.
Requirements
- Proven experience of leading the regulatory aspects of clinical studies on an international basis.
- Some experience of leading small project teams, and line management of regulatory associates.
- Ability to cope with the demands of multiple projects.
- A minimum of a science based Bachelors degree with a higher level qualification preferred.
Responsibilities
- Assume responsibility to act as Lead RAM for a study, as assigned by the Head of RA department, and be responsible for the regulatory management of that trial which includes development of Regulatory Management Plan, study specific FMEA and final review of CSR from regulatory aspects.
- To provide regulatory training to more junior regulatory staff.
- Evaluate / summarize data; prepare and submit documentation related to clinical studies (CTA, any amendments, end of study notifications, study progress reports, CSR submission etc.) to the relevant regulatory authorities, and act on the Sponsors behalf in liaising with these authorities.
- Primary point of contact for the Sponsor’s regulatory group. Responsible for requesting / receiving all Sponsor’s regulatory documentation to support the Clinical study application.
Location
You can be office or home based in any country we have an office.
Why Should You Apply?
- You want to be involved in a wide range of interesting projects and studies.
- You want your achievements and hard work to be recognized.
- You want to work for a growing company where you can progress in your career and where there are opportunities for advancement.
- You want to work in a company that has a great reputation with its clients and employees, and invests in its relationships with both.
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Regulatory Affairs Manager employer: Uniting Holding
Contact Detail:
Uniting Holding Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that Regulatory Affairs Manager role.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. We want to see your passion for drug development and how you can contribute to our mission. Show us you’re not just another candidate, but someone who truly cares about improving patients' lives.
✨Tip Number 3
Practice your answers to common interview questions, especially those related to regulatory management. We love candidates who can articulate their experience clearly and confidently. Mock interviews with friends or mentors can really help!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we’re always looking for passionate individuals who want to grow with us at Ergomed.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your relevant experience in leading regulatory aspects of clinical studies and managing project teams. We want to see how your background aligns with our needs!
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 you can contribute to our mission at Ergomed. Keep it concise but impactful – we love a good story!
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you've successfully managed regulatory submissions or led projects. We appreciate candidates who can demonstrate their impact.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Uniting Holding
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines relevant to clinical studies. Being able to discuss specific regulatory frameworks and how they apply to the role will show that you're not just familiar with the basics, but that you’re genuinely engaged with the field.
✨Showcase Your Leadership Skills
As a Regulatory Affairs Manager, you'll be leading teams and managing projects. Prepare examples of how you've successfully led small project teams in the past, highlighting your ability to handle multiple projects simultaneously. This will demonstrate your capability to manage and mentor junior staff effectively.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or scenarios. Think about past experiences where you had to navigate complex regulatory issues and be ready to explain your thought process and the outcomes. This will help interviewers see your problem-solving skills in action.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about the company’s approach to regulatory management or how they support their employees' professional development. This shows your interest in the role and helps you gauge if the company is the right fit for you.
