(Senior) Regulatory Affairs Specialist (Home-Based) – IQVIA Biotech 50 views

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

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 .

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