Regulatory Affairs – Start up – Manager ()

PRA

As a leading CRO, PRA is transforming clinical trials through our people, innovation and transparency. We combine therapeutic and operational expertise with local knowledge to serve clients across all phases of drug development. Our successful history of helping to bring new drugs to market demonstrates our successful approach to clinical research.

PRA supports our global reach through flexible and reliable service delivery. Thanks to our advanced technological tools and finely tuned systems, we achieve seamless delivery and operational transparency throughout our organization. PRA’s dynamic services and forward-thinking approach are making a difference to healthcare patients worldwide.

As a Manager within the Global Regulatory Affairs department you will manage and coordinate resources and review workload for all direct reports. You will also provide technical advice and support for clinical trials applications, regulatory requirements for study start-up and clinical trials application maintenance for both internal customers and external clients. Your responsibilities will also include:

Preparation and coordination of global regulatory submissions to support the initiation of clinical trials for investigational drugs

Serving as a regulatory lead on multiple projects

Providing support to Business Development

Interaction with Regulatory Agencies, Competent Authorities and Ethics Committees

The successful candidate will have an undergraduate degree (or equivalent) and have three to five years of experience, either leading projects or leading a team within a regulatory environment. You will have experience in managing clinical trials submissions in accordance with the Clinical Trials Directive, in a multi-country environment and have the ability to develop methods, techniques and evaluate criteria in a regulated environment. You must demonstrate abilities in scientific creativity and collaboration with others.

Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.