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- Tasks: Support regulatory submissions and ensure compliance with clinical trial regulations.
- Company: Proclinical, a leading life sciences recruiter with a global reach.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Why this job: Join a dynamic team and make a real impact in the life sciences sector.
- Qualifications: Degree in life sciences and experience in regulatory submissions.
- Other info: Collaborative environment with excellent career advancement opportunities.
The predicted salary is between 36000 - 60000 £ per year.
Proclinical is seeking a Regulatory Clinical Consultant to support regulatory submissions and ensure compliance with clinical trial regulations. In this role, you will independently prepare, review, and approve regulatory documents, provide technical-scientific input, and oversee marketing authorization readiness. You will also collaborate with cross-functional teams and serve as a subject matter expert for regulatory systems. This is a remote-based position reporting to the Director of Regulatory Affairs.
Responsibilities CTA:
- Plan, review and approve regulatory submissions for JCR clinical trials.
- Ensure the timely completion of activities, adhering to agreed timelines, budgets, and deliverables.
- Maintain regulatory oversight of clinical CROs initiating and maintaining JCR clinical trials; this includes meeting attendance.
- Provide regulatory review of study documents.
- Serve as clinical regulatory expert within JCR and with relevant CROs.
- Maintain accurate documentation in internal systems, databases, and study plans according to applicable SOPs.
- Work as an SME for the CTIS/IRAS portals advising on how to use these systems.
- Offer guidance on submissions expertise to junior team members.
Responsibilities regulatory submission:
- Develop and maintain compliant content plans for submissions across the US/EU markets.
- Oversee submission planning, document collection, and content plan execution from an operational standpoint. Track submission progress.
- Draft and review Module 1 documents, including cover letters and regulatory forms.
- Collaborate with Global and Regional Regulatory Leads, publishing team, and internal stakeholders to align on timelines and resolve submission related challenges.
- Additional tasks may be assigned, as required.
Minimum qualifications, knowledge and skills:
- Degree in a life science related discipline.
- Solid understanding of clinical research regulations, directives, and guidance.
- Comprehensive regulatory and technical expertise with the ability to resolve issues in a flexible and adaptable manner. Strong problem-solving abilities and a solution-driven approach.
- Strong ownership skills and the ability to lead meetings and initiatives.
- Ability to manage multiple projects through cross functional teams while maintaining quality and meeting timelines.
- Experience in suggesting process improvements and revisions to SOPs.
- Excellent team collaboration skills.
- Exceptional written and oral communication
- Proficiency in using regulatory IT platforms and tools.
Minimum required experience:
- EU Clinical Trials Regulation knowledge and experience.
- Experience with global clinical trial application submissions.
- Experience in regulatory submission management/project management.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click \’Apply\’ or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you\’ve read and understood our privacy policy, which informs you how we process and safeguard your data – https://www.proclinical.com/privacy-policy
Regulatory Clinical Consultant employer: Proclinical Staffing
Contact Detail:
Proclinical Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Clinical Consultant
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend virtual events, and engage with professionals on LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can land you that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. We recommend practising common interview questions and even role-playing with a friend. The more comfortable you are, the better you’ll shine when it’s your turn to impress!
✨Tip Number 3
Showcase your expertise! During interviews, don’t shy away from discussing your past experiences and how they relate to the role. We want to hear about your problem-solving skills and how you’ve tackled challenges in regulatory submissions.
✨Tip Number 4
Apply through our website! It’s the easiest way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who fit our values, so make sure to highlight why you’d be a great addition to the team!
We think you need these skills to ace Regulatory Clinical Consultant
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Regulatory Clinical Consultant role. Highlight your relevant experience in regulatory submissions and compliance, as this will show us that you understand what we're looking for.
Showcase Your Expertise: Don’t hold back on demonstrating your knowledge of clinical research regulations and your experience with global clinical trial applications. We want to see how your skills align with our needs, so be specific about your achievements!
Be Clear and Concise: When writing your application, keep it straightforward and to the point. Use clear language and avoid jargon unless it's relevant. This will help us quickly grasp your qualifications and fit for the role.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the easiest way for us to receive your application and ensures you’re considered for the position. Plus, it shows us you're keen on joining our team!
How to prepare for a job interview at Proclinical Staffing
✨Know Your Regulations
Make sure you brush up on the latest clinical research regulations and directives. Being able to discuss these confidently will show that you’re not just familiar with the rules, but that you can apply them effectively in your role.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've tackled challenges in previous roles, especially those related to regulatory submissions. This will demonstrate your solution-driven approach and ability to adapt to changing circumstances.
✨Highlight Your Team Collaboration
Since this role involves working with cross-functional teams, be ready to share experiences where you successfully collaborated with others. Emphasise your communication skills and how you’ve led initiatives or meetings.
✨Familiarise Yourself with Regulatory IT Platforms
If you have experience with specific regulatory IT platforms, make sure to mention it. If not, do a bit of research on common tools used in the industry. Showing that you’re tech-savvy can set you apart from other candidates.