Regions
MAIN/REGIONS
regions/
Regions
  1. Americas
  2. Asia & Oceania
  3. Europe
  4. Middle East & Africa
  1. Solutions
  2. Products
  3. Insights
  4. About
  5. Careers
  6. Contact Us
MAIN/search
MAIN/Solutions
Solutions/
SOLUTIONS
  • Research & Development
  • Real World Evidence
  • Commercialization
  • Safety & Regulatory Compliance
  • Technologies
LIFE SCIENCE SEGMENTS
HEALTHCARE SEGMENTS
THERAPEUTIC AREAS

Impacting People's Lives

"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.

LEARN MORE
Harness the power to transform clinical development

Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.

Research & Development Overview
Research & Development Quick Links
Real World Evidence. Real Confidence. Real Results.

Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.

REAL WORLD EVIDENCE OVERVIEW
Real World Evidence Quick Links
See markets more clearly. Opportunities more often.

Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.

COMMERCIALIZATION OVERVIEW
Commercialization Quick Links
Service driven. Tech-enabled. Integrated compliance.

Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.

COMPLIANCE OVERVIEW
Safety & Regulatory Compliance Quick Links
Intelligence that transforms life sciences end-to-end.

When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.

TECHNOLOGIES OVERVIEW
Technology Quick Links
MAIN/Products
Products/
CLINICAL PRODUCTS
COMMERCIAL PRODUCTS
COMPLIANCE, SAFETY, REG PRODUCTS
REAL WORLD PRODUCTS

CASE STUDY

"Data in a Day

LEARN MORE
MAIN/Insights
Insights/
BLOGS, WHITE PAPERS & CASE STUDIES

Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.

DISCOVER INSIGHTS
THE IQVIA INSTITUTE

An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.

SEE LATEST REPORTS

INSTITUTE REPORT

"Global Trends in R&D 2023

READ MORE

EMEA Insights

"IQVIA thought leadership with a focus on EMEA.

Learn more

WHITE PAPER

"DCTs Deliver Big ROI

LEARN MORE

WHITE PAPER

"Capturing value at scale: The $4 billion RWE imperative

LEARN MORE
MAIN/About
About/
FEATURED INNOVATIONS
  • Connected Intelligence
  • AI & Machine Learning
  • Human Data Science Cloud
  • IQVIA Innovation Hub
  • Decentralized Trials
  • Genomics
WHO WE ARE
NEWS & RESOURCES

INVESTOR RELATIONS

"Visit our investor relations site for more information.

LEARN MORE
Unlock your potential to drive healthcare forward

By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.

LEARN MORE
AI & Machine Learning with a healthcare IQ.

Artificial intelligence is accelerating opportunities. Realizing the benefits for healthcare requires the right expertise. Together, we can solve the problems of today, and drive the breakthroughs of tomorrow.

LEARN MORE
Your healthcare data deserves more than just a cloud.

The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.

LEARN MORE
Innovations make an impact when bold ideas meet powerful partnerships

The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners. Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.

LEARN MORE
Proven, faster DCT solutions

IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.

LEARN MORE
Unlock the power of genomic research.

IQVIA enables genomic research via global access to a network of genomic-clinical data, proprietary technologies that enable federated analytics, and therapeutic area & bioinformatics expertise to help you answer your most pressing research questions.

LEARN MORE
MAIN/Careers
Careers/
WORKING AT IQVIA

Our mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.

LEARN MORE
LIFE AT IQVIA

Careers, culture and everything in between. Find out what’s going on right here, right now.

LEARN MORE

WE’RE HIRING

"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.

SEARCH JOBS
MAIN/Contact Us
Contact Us/
White Paper
The Evolution of Regulatory Affairs
Outsourcing and automation of routine tasks has regulatory professionals rethinking their roles.
  • Library
  • The Evolution of Regulatory Affairs
To download files, please accept Functional Cookies. These cookies provide enhanced functionality for a better user experience.

The regulatory affairs role in the pharmaceutical industry is rapidly changing, with many of the tasks once aligned with in-house experts being outsourced or automated by developing technology. This trend is forcing industry professionals to rethink their role and establish themselves as thought leaders who bring measurable strategic value to their company’s business. This insight brief examines the shift of regulatory affairs work to local hubs, which is creating new opportunities for regulatory professionals to work directly with regulators, provide thought leadership input within their respective organizations, and support product development as the profession continues to evolve. Based on market leadership with over 7,000 product registrations serviced in over 150 countries since 2015, this insight brief shares global regulatory affairs insights from IQVIA with partner Bristol-Myers Squibb on the evolution and anticipated future of the regulatory affairs profession and industry.

Introduction: The Long view

Over the past several decades, the trajectory of the Regulatory Affairs function has evolved to its current position at the hub of the development wheel and a dynamic engine of R&D (Figure 1). In terms of outsourcing Regulatory Affairs tasks, we can look back a decade or so to Data Management and Biostatistics functions, which were primarily country- or region-based with similar work conducted in many different geographies. In contrast, today, many staff within these functions are located offshore and are coordinated by global project managers, often based in developed countries. In addition, we are seeing a rapid acceleration of compounds originating outside of the companies ultimately responsible for marketing them. A decade ago, one-third of approved drugs sold by big pharma companies were sourced from outside their organizations. Today, this has risen to between 51% and 70%.

Past And Present

Ten years ago, a regulatory affairs specialist could expect to start out in a role at a company’s headquarters or regional affiliate, working on all aspects of regulatory affairs, covering country- or region-specific projects only.

Today, the regulatory affairs profession is changing as the outsourcing sector matures, and as technologies and processes advance. Regulatory affairs professionals now typically focus on a single sub-process, often working in siloes, and with a risk of not fully understanding the entire scope of product development.

 

DOWNLOAD TO READ MORE

Related solutions

Regulatory Compliance

Automate and standardize your regulatory management, from correspondence and commitments to registration and tracking.

Safety & Regulatory Compliance

Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.

Patient Recruitment

Predict enrollment more accurately and increase the number of patients per site using data-driven patient recruitment solutions.

Contact Us