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IQVIA Regulatory Staff Augmentation Services
The benefits of flexible regulatory subject matter experts without expanding your internal teams
Rama Mohan Rao Chikkam, Senior Director, Global Regulatory Operations and APAC RA, Regulatory Affairs and Drug Development Solutions, IQVIA
Marcela Miño, Global Head, Lifecycle Management & Regulatory Affairs, IQVIA
Oct 22, 2024

Navigating the complexities of the life sciences industry, especially in a changing regulatory landscape, requires a qualified and available regulatory workforce. Complexity is compounded with our dynamic environment of continuous process improvement, new technology integrations, asset acquisitions and divestments and new process/tool implementations to comply with changing regulations. During such critical periods, quickly addressing resource gaps is critically important to ensuring business continuity and strict regulatory compliance. IQVIA’s expert Regulatory Affairs & Drug Development Solutions team can efficiently manage your regulatory staffing needs, making your budgets and targets easier to achieve. With global availability and adaptable regulatory staffing models, IQVIA provides flexibility and confidence to meet your broader end-to-end regulatory vision with a focus on regulatory global expansion, innovation, technology and sustainability of your business.

IQVIA’s strategic regulatory staff augmentation services are designed to meet these demands, providing you with the skilled professionals you need, precisely when you need them.

IQVIA partners with pharma, biotech and MedTech companies of all sizes to transform your functional management and regulatory outsourcing approach, helping you select the right services, tools and technologies to streamline processes. The result is custom-built, scalable solutions that enhance efficiency, quality and consistency while providing cost-effective flexibility for your growing or changing organization.

With over 40 years of experience in regulatory services, IQVIA offers insights into evaluating regulatory staffing needs for the whole spectrum of regulatory activities across all product types, ranging from small molecules to biologics and medical devices. IQVIA’s regulatory expertise supports companies of all sizes, from emerging biotech to global pharma, in meeting staffing needs on time.


Key benefits of IQVIA’s regulatory staff augmentation support:
  • Global talent pool: Access a vast network of over 3,300 regulatory professionals across 100+ countries to fill specific expertise and gain flexibility to quickly ramp up or down to meet your resource needs.
  • Expert talent acquisition: Use the power of our internal dedicated team of 450 hiring specialists operating globally.
  • Transition champions: Ensure rapid, seamless transitions carefully planned and driven by our experienced transition leads who have led multiple partnership implementations.
  • Robust governance: Rely on consistent and reliable operations oversight, support, communications and risk mitigation and management through our well-established governance framework.
  • Proven partnerships: Gain from the experience and best practices we apply from over 500 successful regulatory partnerships.
  • Advanced technology: Benefit from enhanced efficiency and accuracy powered by our cutting-edge AI/ML-powered technology and regulatory intelligence tools. 

Representative list of domain-specific regulatory experts:

Regulatory Affairs

  • Regulatory Strategist/Senior Strategist
  • Regulatory Lifecycle Maintenance Specialist/Senior Specialist
  • Regulatory Project Manager
  • Regulatory Dossier Specialist
  • Submission Planner/Global Dossier Coordinator
  • Market Authorization Transfer Specialist (Asset Acquisition/Divestment and Company Merger/Spinoff)
  • Regulatory Intelligence Expert
 

CMC Experts

  • Regulatory CMC Author
  • Developmental CMC Strategist
  • Regulatory CMC Manager/Senior Manager
  • CMC Project Manager
  • CMC Data and Digital Experts
  • CMC Specialist/Senior Specialist
  • CMC Change Control Assessment Expert
 

Regulatory labeling

  • Global Labeling Lead/Labeling Strategist
  • Labeling Specialist/Senior Specialist
  • Labeling Manager/Senior Manager
  • Labeling Operations Coordinator
  • Labeling Compliance Specialist
  • Labeling Associates/Senior Associates
  • Labeling Artwork Specialist
  • Labeling Proofreaders
 

Publishing and Submission manager

  • Publisher/Senior Publisher
  • Submission Manager/Senior Submission Manager
  • Styling Expert/Format Specialist
  • Document Administrator
  • Publishing Technology Specialist
  • Publishing Consultant
 

Regulatory information management (RIM)

  • RIM Strategist
  • Data Migration Expert
  • Technology Adoption Consultant
  • XEVMPD/IDMP Experts
  • RIM Data Maintenance Expert
  • RIM Data Manager/Senior Manager

IQVIA’s domain-specific expertise, proven partnerships, robust governance, and strategic strengths in regulatory staff augmentation support provide unparalleled advantages for your regulatory affairs needs. Our global talent pool and dedicated hiring specialists ensure that you receive the most qualified regulatory professionals to drive your projects forward efficiently and effectively.

Contact us today to discover how our tailored, flexible regulatory staff augmentation services can be customized to meet your unique requirements. Let IQVIA partner with you to achieve excellence in regulatory staffing and enhance your operational success.

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