At a Glance
- Tasks: Coordinate regulatory submissions for clinical trials and ensure compliance with regulations.
- Company: Join Medpace, a leading clinical operations company in London.
- Benefits: Enjoy flexible work, competitive pay, and great career growth opportunities.
- Other info: Be part of a dynamic team with a focus on employee wellness and appreciation.
- Why this job: Make a real impact in clinical research while developing your skills.
- Qualifications: Bachelor's degree in Life Sciences and experience with regulatory documentation required.
The predicted salary is between 40000 - 50000 € per year.
Department: Site Activation & Maintenance
Location: London
Our clinical operations activities are growing rapidly, and we are currently seeking an experienced Regulatory Submissions Coordinator to join our Clinical Operations team in the UK. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Please note that this is an office-based position in London.
Responsibilities
- Prepare, review, and file initial clinical trial applications to regulatory authorities;
- Prepare and submit responses to queries and amendments to clinical trial applications;
- Ensure submissions comply with applicable regulations and guidance documents;
- Advise team members on changing regulations and compliance requirements;
- Maintain the Clinical Trial Management System and ensure timely filing of documents;
- Collection of essential documents and preparation essential documents packages for drug release.
Qualifications
- A minimum of a Bachelor's degree is required (preferably in a Life Sciences field);
- Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries;
- Relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
- Knowledge of regulatory guidelines in the UK;
- Excellent organizational and prioritization skills;
- Used to working independently with a proactive approach;
- Knowledge of Microsoft Office;
- Great attention to detail and excellent oral and written communication skills.
Medpace Perks
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
Regulatory Submissions Coordinator (Study Start Up) employer: Medspace
Medpace is an exceptional employer that offers a dynamic and supportive work environment in the heart of London. With a strong focus on employee growth, we provide structured career paths and numerous professional development opportunities, alongside competitive compensation and benefits. Our commitment to employee wellness and appreciation events fosters a collaborative culture where your contributions are valued and recognised.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Submissions Coordinator (Study Start Up)
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for informational interviews. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for interviews by researching the company and the role thoroughly. We recommend practising common interview questions and even role-playing with a friend. The more prepared you are, the more confident you'll feel when it’s time to shine!
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the position. We suggest mentioning something specific from the interview to remind them of your great conversation.
✨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 love seeing familiar names pop up in our system!
We think you need these skills to ace Regulatory Submissions Coordinator (Study Start Up)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Submissions Coordinator role. Highlight your experience with regulatory documentation and any relevant qualifications. We want to see how your background fits perfectly 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 clinical operations and how your skills align with our needs. Keep it engaging and personal – we love to see your personality come through!
Showcase Your Attention to Detail:In this role, attention to detail is key. Make sure your application is free from typos and errors. We appreciate candidates who take the time to double-check their work, as it reflects the quality we strive for at StudySmarter.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just follow the prompts and submit your materials!
How to prepare for a job interview at Medspace
✨Know Your Regulations
Make sure you brush up on the latest UK regulatory guidelines. Being able to discuss these confidently will show that you're not just familiar with the basics, but that you’re proactive about staying updated in this fast-paced field.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully prepared and submitted regulatory documentation. Highlight any challenges you faced and how you overcame them, as this will demonstrate your problem-solving skills and experience.
✨Organisational Skills Matter
Since this role requires excellent organisational skills, be ready to discuss how you manage multiple tasks and deadlines. You could even share a time when your organisational skills made a significant impact on a project.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the team dynamics or how they handle changes in regulations. This shows your genuine interest in the role and helps you assess if it’s the right fit for you.
