Regulatory affairs officer II

  • Company:
    IQVIA
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    44 seconds ago
  • Category:
    General

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

**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; Responsibilities Essential Functions

+ 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;

_Join Us_

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.

Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.

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