Regulatory Affairs Consultant

2 weeks ago

King of Prussia, United States Parexel International Corporation Full time

Regulatory Affairs Consultant must have an understanding of the organization‘s consulting models and methodologies, as well as good knowledge of what services PC provides. The Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Lead or Work Stream Lead, a consultant secures the work of the entire team or work stream is delivered on time and that it meets client‘s and PC‘s quality.

Skills and knowledge:

  • Regulatory Affairs Consultant should have solid local expertise in submitting Clinical Trials to Health Authority in Brazil.
  • This role will be responsible for managing and coordinating the regulatory submission strategy for a large number of clinical trials in Brazil. Also, will coordinate and manage flow of information, track project progress, and identify and solve problems in a team-oriented environment.
  • As part of the more relevant tasks, it will review critical key technical documents (e.g. clinical trial protocols and reports, study drug labels, and other clinical trial related technical documentation) to ensure regulatory compliance for clinical trial applications, consistency with other key documents and ease of review. The Consultant supports the sponsor for the development of optimized clinical trial submission strategies.
  • Good communication and leadership skills as well as team player attitude is needed to be successful in this position. Detail orientation and flexibility will be highly appreciated as well.

We are looking for candidates with experience in these activities developed in CRO or similar organizations. The Regulatory Affairs Consultant should be able to work independently with minimum need of direct supervision.

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