GLOBAL REGULATORY AFFAIRS SPECIALIST

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 • Strong, global CMC and RA LCM experience, pharmaceutical\/chemical (or similar) scientific background.
• Well - organized, team player, goal oriented, proactive and motivated worker.
Great communication, cooperation skills.
• 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 procedures 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 IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
Learn more at https.
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