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- Tasks: Lead regulatory management for clinical studies and provide training to junior staff.
- Company: Join Ergomed, a growing international CRO with a passion for improving patient lives.
- Benefits: Competitive salary, great benefits, and opportunities for career advancement.
- Other info: Flexible work options available; work from home or any of our global offices.
- Why this job: Be part of exciting projects that make a real difference in drug development.
- Qualifications: Experience in regulatory affairs and a science-based degree required.
The predicted salary is between 36000 - 60000 £ per year.
We offer an opportunity to learn, progress and achieve, in a dynamic growing environment. 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.
The Company: 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 patients' 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.
The 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.
Regulatory Affairs Manager in Guildford employer: Ergomed
Contact Detail:
Ergomed Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager in Guildford
✨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 noticed. Plus, we’re always looking for talented individuals who are eager to grow with us in this dynamic environment.
We think you need these skills to ace Regulatory Affairs Manager in Guildford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your relevant experience and skills that match the job description. We want to see how you can bring value to our team!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you're passionate about regulatory affairs and how your background makes you a perfect fit for our dynamic environment. Keep it engaging and personal!
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you've led projects or improved processes in previous roles. We love to see results and how you’ve made an 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 Ergomed
✨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
Since the role involves leading small project teams, be prepared to share examples of your past leadership experiences. Talk about how you managed projects, supported team members, and navigated challenges. This will demonstrate your capability to lead effectively in a dynamic environment.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or project scenarios. Think through potential situations you might face as a Regulatory Affairs Manager and prepare structured responses that highlight your problem-solving skills and regulatory knowledge.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions about the company’s projects, team dynamics, or future goals. This shows your interest in the role and helps you gauge if the company is the right fit for you. Plus, it gives you a chance to engage with the interviewers on a deeper level.