Regulatory Affairs Specialist

**Job Overview****Essential Functions**:- Acts as a Regulatory Team Leader on more complex projects, which may include technical writing; - Prepares and/or reviews regulatory documentation in area of expertise, as appropriate; - Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments; - Acts as an SME/ expertin Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable; - May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development; - May present to clientson complex regulatory processes at large full service bid defense meetings by phone or in person; - May act as reviewer for regulatory standard operating procedures, as assigned and appropriate; - May prepare and deliver regulatory training to IQVIA small groups or individuals; - Performs other tasks or assignments, as delegated by Regulatory management**Qualifications**:- Bachelor's/ Master´s Degree in Lifescience or related discipline- At least 3-4 years relevant experience- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate; - Possesses a specific regulatory or technical expertise; - Ability to establish and maintain effective working relationships with coworkers, managers and clients; - Ability to work on several projects, with direction from senior staff as appropriate