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:
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