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Regulatory Project Manager

IQVIA

  • Durham, North Carolina
  • 4 days ago

    Highlights

    The role will partner closely with Global Regulatory Leads and cross-functional stakeholders to translate regulatory strategy into integrated, executable plans; manage key milestones, timelines, dependencies, risks, and regulatory deliverables; and help drive alignment and accountability across global regulatory teams. The individual will also support effective Global Regulatory Subteam governance, including meeting planning and facilitation, decision and action tracking, stakeholder communication, and follow-through on key regulatory activities.

    Numbers & Facts

    LocationDurham, North Carolina
    IndustryHealthcare Services
    Company Size10,000 employees or more
    Year Founded1982
    Websitehttps://www.iqvia.com/

    Description

    The individual will support one or more global development programs as part of our Global Regulatory Science organization. The specific therapeutic area and program assignment will be determined based on the candidate’s experience, capabilities, and fit with the team. This individual will support across both early- and late-stage development programs.
     
    The role will partner closely with Global Regulatory Leads and cross-functional stakeholders to translate regulatory strategy into integrated, executable plans; manage key milestones, timelines, dependencies, risks, and regulatory deliverables; and help drive alignment and accountability across global regulatory teams. The individual will also support effective Global Regulatory Subteam governance, including meeting planning and facilitation, decision and action tracking, stakeholder communication, and follow-through on key regulatory activities.
     
    Candidates with strong experience supporting global regulatory development programs, with particular emphasis on the US, EU, Canada, Australia, and UK. Exposure to APAC and LATAM markets is desirable, although deep regional expertise in those geographies is not required.
     
    Ideal candidates will have:
    •    Significant pharmaceutical or biotechnology experience, including substantial experience in regulatory affairs and/or regulatory program management.
    •    Experience supporting regulatory strategy and execution across development stages, including major submissions, global registration activities, and, where applicable, post-marketing activities.
    •    Strong project and program management capabilities, including management of complex timelines, interdependencies, risks, and cross-functional deliverables.
    •    Demonstrated ability to work effectively in a matrixed global organization and partner with senior regulatory and cross-functional stakeholders.
    •    Strong communication, facilitation, organizational, and influencing skills.
    •    Familiarity with regulatory systems and tools; experience with Smartsheet, Microsoft Office/PPT-based timeline visualization tools, and Veeva RIM would be beneficial.

    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 https://jobs.iqvia.com

    IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

    IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

    The potential base pay range for this role, when annualized, is $97,200.00 - $270,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

    About Company

    IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology and human intelligence to reimagine and deliver ways to help make them a reality. It’s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It’s about exploring a new path to better health outcomes via Human Data Science. It’s about harnessing the power of the IQVIA CORE™ to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers. Motivated by the industry we help, we’re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward.

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