Senior Regulatory Affairs Associate

Senior Regulatory Affairs Associate must understand the organization's consulting models and methodologies, as well having as good knowledge of what services PC provides. The Senior Regulatory Affairs Associate must have good 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. This position secures the work is delivered on time and that it meets client's and PC's quality expectations.

Skills and knowledge:

• Senior Regulatory Affairs Associate should have good local expertise in submitting Clinical Trials to Health Authority in Brazil - ANVISA.
• This role will be responsible for managing and coordinating the local regulatory submission strategy for many 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.
• Good communication and teamwork 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. Its mandatory that interested candidates have experience with compiling and submitting documentation to local MOH (Anvisa). Also, candidates must have worked supporting Clinical Trials.

Good English skills are necessary.