At a Glance
- 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.
- Other info: Collaborative environment with excellent career advancement opportunities.
- 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.
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
Locations
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 help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and understanding their values. 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! When you get the chance to chat with potential employers, don’t hold back on sharing your knowledge about regulatory submissions and clinical trials. We want to see you as the go-to person they need for the role.
✨Tip Number 4
Apply through our website! It’s super easy and ensures your application gets the attention it deserves. Plus, we’re always looking for passionate individuals like you to join our team, so don’t hesitate to hit that 'Apply' button!
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 to highlight your experience with regulatory submissions and clinical trial regulations. We want to see how your skills align with the role of Regulatory Clinical Consultant, so don’t hold back!
Showcase Your Expertise: Use your application to demonstrate your solid understanding of clinical research regulations and your problem-solving abilities. We love seeing candidates who can flexibly adapt and resolve issues, so share specific examples from your past experiences.
Be Clear and Concise: When writing your application, keep it clear and to the point. We appreciate well-structured documents that are easy to read. Make sure to proofread for any typos or errors – clarity is key in regulatory roles!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity. Plus, it’s super easy to do!
How to prepare for a job interview at Proclinical Staffing
✨Know Your Regulations
Make sure you brush up on the latest clinical trial regulations and directives. Being able to discuss these confidently will show that you’re not just familiar with the basics, but that you’re genuinely engaged with the field.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've tackled regulatory challenges in the past. This role requires a solution-driven approach, so having specific instances ready will demonstrate your capability to handle complex issues effectively.
✨Highlight Your Team Collaboration
Since this position involves working with cross-functional teams, be ready to discuss your experience in collaborative environments. Share stories that illustrate your ability to lead meetings and initiatives while maintaining quality and timelines.
✨Familiarise Yourself with Regulatory IT Platforms
As proficiency in regulatory IT platforms is key, make sure you can talk about your experience with these tools. If you’ve used specific systems like CTIS or IRAS, mention them and explain how they helped streamline your work.