Regulatory Affairs Specialist

Job Description

Job Overview Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision. 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/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable; Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate; 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 clients on 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 Bachelors Degree Degree in Lifescience or related discipline Req Or Masters Degree Degree in Lifescience or related discipline Req 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; Good, solid interpersonal communication (oral and written) and organisation skills; Ability to establish and maintain effective working relationships with coworkers, managers and clients; Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable; Demonstrates self-motivation and enthusiasm; Ability to work on several projects, with direction from senior staff as appropriate; Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements; Ability to make decisions on discrete tasks under senior supervision; Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education; Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area; Problems faced are general and may require understanding of broader set of issues, but typically are not complex; Ability to adapt quickly to a rapidly changing environment; Applicable certifications and licenses as required by country, state, and/or other regulatory bodies . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com