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Regulatory Affairs Specialist

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Primary Location: Reading, Berkshire, United Kingdom Additonal Locations: Oeiras, Portugal,PRT; Warsaw, Poland,POL Full time R1189223

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 Life Science or related discipline or
• Master's Degree Degree in Life Science 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;
• Good, solid interpersonal communication (oral and written) and organization 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

At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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