Regulatory Affairs
The Regulatory Affairs department is responsible for obtaining approval to initiate clinical trials for new products, as well as ensuring that approval is maintained. It serves as the interface between the regulatory authority and the project team.
The Regulatory Affairs department is responsible for obtaining approval to initiate clinical trials for new products, as well as ensuring that approval is maintained. It serves as the interface between the regulatory authority and the project team.
Key Positions
Medical Writing
Writes IND modules, NDA modules and other related regulatory documents. Writes clinical study reports, protocols, and protocol amendments. Coordinates quality control reviews of those documents and maintain audit trails of changes. Interacts closely with the sponsor, and other Medpace subject matter experts.
Regulatory Project Management
Serves as the primary point of contact for Sponsors and regulatory authorities. Manages projects and programs with multiple regulatory deliverables, with a particular focus on Investigational New Drug (IND) applications. Maintains close collaboration, interaction, and effective working relationships with Medpace functional area colleague.
Regulatory Documentation
Publishes Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards. Performs document quality control checks for others in the department, promptly communicating irregularities in documents and coordinating issue resolution. Develops understanding and maintain knowledge of appropriate standard operating procedures (SOPs), regulations, policies, and regulatory guidance documents.
Degrees, Qualities, and Competencies
What We Look For
We seek the best to be the best. A superb resumé is a good start, but there are other attributes we look for.
Related Degrees
A PhD and a background in Medical Writing are required. Regulatory Project Managers and Document Specialists require a Bachelor’s in Life Science required. A Masters is preferred.
Related Experience
1-2 years of experience in a pharmaceutical or CRO setting is preferred, but not required. Related experience isn’t required for entry-level positions.
Attention to Detail
Accomplish tasks while demonstrating a thorough concern for all the areas involved, no matter how small. This means monitoring and checking work or information while organizing time and resources efficiently.
Medpace People
Our CRAs are ultimately saving patient lives every single day, and that is extremely rewarding to be a part of.
Julia Winterhalter
Senior Director, Clinical Monitoring
The ultimate goal is to help people. We know that we are a part of the team that is creating these drugs and devices to help people and to make their lives better.
Courtney Busemeyer
Vice President, Data Sciences
What gets exciting for me is that I’m able to take my experience in technology and bring it to bear in a place where it’s going to make an impact.
Brandon Ebken
Chief Information Officer
Welcome to your future.
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