Regulatory Clinical Consultant

Proclinical Group; London; Remote; GBP 150,000 - 200,000; Full time

Job summary

A leading life sciences recruiter is seeking a Regulatory Clinical Consultant to prepare and review regulatory documents and support compliance with clinical trial regulations. This remote role requires solid knowledge in regulatory submissions and excellent team collaboration skills. The ideal candidate should have a degree in a life science discipline and experience with global clinical trial applications.

Qualifications

• Solid understanding of EU Clinical Trials Regulation.
• Ability to manage multiple projects through cross-functional teams.
• Experience in regulatory submission management and project management.

Responsibilities

• Plan, review and approve regulatory submissions.
• Ensure timely completion of activities.
• Maintain regulatory oversight of clinical CROs.

Skills

Clinical research regulations understanding

Regulatory submission management

Team collaboration skills

Problem-solving abilities

Proficiency in regulatory IT tools

Education

Degree in life science related discipline

Job description

Overview

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

• 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.
• 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 and project management.

How to apply

If you are having difficulty applying or if you have any questions, please contact Peter Duvall at [e-mail].

Apply Now: If you are interested in applying to this opportunity, please click 'Apply' or 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.

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