Regulatory Affairs Associate

Medpace Cincinnati , OH 45201

Posted 7 days ago

Overview

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 approximately 3,500 people across almost 40 countries.

Job Summary

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Affairs Associate to join our Regulatory Affairs team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. In addition, this position will be a project manager within the Regulatory Affairs team. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

  • Manage multiple projects while ensure timely completion of tasks and overall completion;

  • Manage IND and NDA project deliverables and timelines;

  • Maintain timelines for components of regulatory deliverables;

  • Prepare regulatory documents for submission to the FDA, including writing, publishing, correct placement in eCTD hierarchy;

  • Conduct meetings with internal teams, Sponsors, and FDA as needed, including meeting agendas, minutes, action items;

  • Maintain Regulatory records, including archive of submissions and FDA correspondences files;

  • Ensure submissions comply with applicable regulations and guidance documents;

  • Advise clients on regulations as they apply to IND and NDA development;

  • Prepare and deliver regulatory submissions to domestic and international regulatory agencies and scientific advice bodies;

  • Perform document quality control checks in accordance with established processes;

  • Provide day-to-day department support activities to aide completion of project deliverables;

  • Maintain up to date knowledge of regulatory requirements, guidance, and science; and

  • May be responsible for other projects and responsibilities as assigned.

  • In Europe, assist in assessment of dossiers for regulatory applications from a technological/biopharmaceutical perspective;

Qualifications

  • PhD in a life science related field or PharmD

  • At least prior experience or knowledge in the research or pharmaceutical industry or project management experience

  • Strong computer skills, project management skills, and a high attention to detail; and

  • Strong communication skills (both written and oral)

Why Medpace?

When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

Awards:

  • Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer

  • Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability

  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next:

A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.

EO/AA Employer M/F/Disability/Vets

  • WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.
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Regulatory Affairs Associate

Medpace