(Senior) Regulatory Affairs Specialist (Home-Based) – IQVIA Biotech 64 views

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 p

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 . Bachelor’s Degree Degree in Lifescience or related discipline Req Or . Master’s 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

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