Regulatory Affairs Specialist

Available Exclusively for Premium Members
Bloomington, IN
Posted 

Job Description

The organization is seeking a Regulatory Affairs Specialist to support regulatory compliance and operations within the pharmaceutical sector. This hybrid role, based in Bloomington, IN, involves providing regulatory guidance to clients, managing documentation, and ensuring adherence to standards set by agencies such as the FDA and EMA. Key responsibilities include conducting regulatory surveillance, assisting with licensing and audits, and preparing submissions for drug applications. Candidates should possess a bachelor's degree in a relevant field and have 3-5 years of experience in a quality or regulatory role, with a strong understanding of regulatory submissions.