Regulatory Affairs Associate
Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio and we are active in over 40 countries across the globe. We continue to steadily grow and are looking to add to our team!Our European activities are growing rapidly, and we have a new and exciting opportunity to join our Global Regulatory Affairs team as Associate, Regulatory Affairs, on a full-time basis. The position is office based and you will be working with local and international teams supporting clinical development. This position will work with the global team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you can use your previous experience and can develop and grow your career even further, then this is the opportunity for you.RESPONSIBILITIES * Preparation and delivery of regulatory submissions to domestic and international regulatory agencies; * Perform document quality control checks in accordance with established processes; * Maintain timelines for components of regulatory deliverables; * Provide day-to-day department support activities as necessary to aide completion of project deliverables; * Maintain and train on up-to-date regulatory requirements, guidance and science; * May be responsible for other projects and responsibilities as assigned.REQUIREMENTS * Bachelor's Degree in a related field; advanced degree highly preferred (M.D., Pharm.D, Ph.D.); life sciences degrees preferred or Juris Doctorate; * Minimum 18 months of regulatory affairs experience in the Biotechnology, Pharmaceutical or CRO industries; * Experience working directly with domestic regulatory agencies; * Knowledge of and familiarity with the regulations and practices of EU regulatory agencies; * Excellent analytical, written and oral communication skills; and * Strong computer skills and project managements skills, and a high attention to detail; and * Must be a team player.Travel: Minimal InternationalWHY MEDPACE?At Medpace, you will find work that is both challenging and rewarding. At Medpace, you will be given the tools and training to succeed. At Medpace, you will be rewarded for strong performance and provided opportunities to grow professionally.WHAT TO EXPECT NEXTWe look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.