Job Description

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.
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