At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.
As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
Global Regulatory Affairs department is comprised of 190+ regulatory professionals globally with a wealth of experience working with biopharmaceutical companies, and interacting with regulatory authorities and ethics committees
As an Associate Director, Global Regulatory Affairs you will provide scientific and related regulatory expertise regarding preclinical and clinical research and CMC, as well as product development support, for either internal customers or external clients, for investigational medicinal products, including chemical entities, biologicals, biotech products, advanced therapies and medical devices. Participates in project teams or may provide service as an independent expert. Provides regulatory strategy, due diligence, regulatory scientific review of regulatory submissions - NDA/BLA, IND, MAA, CTA, CTD, NDS submissions etc. Leads and coordinates Agency/authority interactions for multiple projects. Provides functional management to the regulatory affairs department staff.
Your responsibilities will also include:
The successful candidate will have an undergraduate degree (or equivalent) and experience in either leading projects or leading a team within a regulatory environment. You will have experience in managing clinical trials submissions in accordance with the CT Directive and/or applicable country regulations 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.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.