Technical & Regulatory Affairs Advisor
3 weeks ago
Regulatory Submissions Technical Advisor (Regulatory Affairs, Study Start-up)
Our clinical operations activities are growing rapidly and we are currently seeking full-time, Regulatory Submissions Technical Advisors to join our Site Activation and Maintenance team, within Clinical Operations.
This position plays a key role at Medpace, p reparing and reviewing regulatory documents and providing strategic regulatory advice to support clinical trial submissions . Provide regulatory submissions strategic advice and guidance to the Regulatory Submissions Manager (RSM), Medpace project team and Sponsor to ensure submissions compliance with appropriate regulations and requirements;
Prepare and/or review core trial documents for compliance with relevant guidelines/regulations and for trial suitability;
Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges;
Independently interact with Sponsors, regulatory agencies and Medpace colleagues; Bachelor’s degree in Life Sciences - Master’s/PhD preferred;
Significant experience in regional/global regulatory submissions;
Strong understanding of regulatory documentation, guidelines and legislation;
Ability to review regulatory guidance and develop proactive solutions to regulatory issues and challenges;
Experience in reviewing and/or writing core regulatory documents;
Ability to independently interact with national/regional regulatory agencies.
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Hybrid work-from-home options (dependent upon position and level)
Competitive PTO packages
Company-sponsored employee appreciation events
Employee health and wellness initiatives
Flexible work schedule
Competitive compensation and benefits package
Structured career paths with opportunities for professional growth
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
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