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Regulatory Affairs Start Up Manager - Homebased

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Primary Location: Buenos Aires, Argentina Additonal Locations: Bogota, Colombia,COL; Lima, Peru,PER; Mexico City, Mexico,MEX; San Jose, Costa Rica,CRI; Santiago, Chile,CHL; Sao Paulo, Brazil,BRA Full time R1228319

Job description

Job Overview
Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline. Works independently under limited supervision.

Essential Functions
• Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate;
• Competently writes regulatory and/or technical documents with minimal review by senior staff;
• Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues;
• 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 at bid defense meetings by phone, for a range of regulatory deliverables, at discretion of senior staff;
• May write new regulatory standard operating procedures, and/or propose revisions and/or act as reviewer for regulatory standard operating procedures, as assigned and appropriate.
• May manage meetings with Regulatory Agencies;
• May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative;

Qualifications
• Bachelor's Degree Degree in Lifescience or related discipline Req Or
• At least 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. Sufficient knowledge of managing regulatory projects, project deliverables on a time bound manner;
• Expert in planning and delivering work on time keeping quality parameter in mind;
• Knowledge of regulatory procedures in appropriate region
• Good working knowledge of regional regulatory intelligence;
• Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
• Ability to adapt quickly to a rapidly changing environment;

Benefits
• Full Homebased position

• Great compensation package

• Career Development

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 70,000+ 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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