Global Regulatory Compliance Expert

3 semanas atrás


Porto Alegre, Brasil beBeeRegulatory Tempo inteiro

Job Overview:

Senior Regulatory Specialist

The role of Senior Regulatory Specialist is pivotal in ensuring timely collection and maintenance of regulatory standards. This individual serves as the primary contact for investigative sites, providing guidance on requirements to EC/IRB/Third body/Regulatory Authorities.

Key Responsibilities include maintaining awareness of country-specific regulatory legislation, coordinating data and information required by authorities, liaising with internal and external vendors, reviewing submission documents for compliance, and preventing escalations of study issues.

Required skills include a university or college degree (life science preferred) or certification in a related allied health profession from an accredited institution, minimum 3 years' experience in clinical development or start-up/regulatory process, working knowledge of ICH, RA, IRB/IEC regulations, and familiarity with investigator start-up documents and contract negotiation process.


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