Regulatory Submissions Technical Advisor (Regulatory Affairs, Study Start-up)
Medpace
- London
- Permanent
- Full-time
- 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;
- Prepare and maintain Part I EU CTR submissions
- Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges;
- Independently interact with Sponsors, regulatory agencies and Medpace colleagues; and
- Present during bid defences, general capabilities meetings and audits, as required.
- 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;
- Strong communication, critical thinking and problem-solving skills;
- Ability to independently interact with national/regional regulatory agencies.
- 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
- Recognized by Forbes as one of America's Best Mid-size Companies in 2021, 2022 and 2023
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility