Regulatory Affairs Officer
7 days ago
Job Overview Under general supervision Prepares and or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and or external clients Provides regulatory support for assigned projects Essential Functions Acts as a Regulatory Team Member on small straightforward regulatory projects and or gets involved in a small single service project under the guidance of senior staff Identifies project needs tracks project timelines implements client requests and manages day-to-day workload in collaboration with senior staff as appropriate Experienced in Regulatory knowledge in Chemistry Manufacturing and Controls Lifecycle Maintenance Marketing Authorization Transfers Labeling Publishing as applicable Prepares and or reviews regulatory documentation in area of expertise as appropriate Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters Understands the Scope of Work deliverables for any given project May prepare slides and background material for small straightforward business development meetings under senior guidance and presents in client meetings by phone or in person May prepare and deliver trainings as appropriate Performs other tasks or assignments as delegated by Regulatory management Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex Qualifications Bachelor s Degree Degree in Lifescience or related discipline Req Or Master s Degree Degree in Lifescience or related discipline Req At least 2 years relevant experience Good understanding of the Research and Development process Chemistry Manufacturing Controls Preclinical and Clinical laws and related guidelines as appropriate 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 Applicable certifications and licenses as required by country state and or other regulatory bodies IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries 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
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