Regulatory Affairs Operations (PH165)

Resources and Tools to Safeguard Submission Success

  • Maximize Regulatory Affairs Efficiency

    Regulatory affairs groups play a pivotal and ever-expanding strategic role in the success of compounds, brands, and whole companies.  Regulatory teams enable organizations to navigate an increasingly complex, global healthcare landscape amid the growing array of regulatory bodies, different and constantly updated guidances, and often struggling product pipelines.

     As the responsibilities of regulatory affairs groups evolve, and these teams move closer to the C-suite, companies dedicate greater investment to their budgets. Despite this resource support, teams face ongoing challenges to balance heavier workloads as the margin for submission errors narrows — making the need for efficiency paramount. Top-performing companies reevaluate and develop innovative approaches to personnel, strategy-setting and processes to gain maximum efficiency.

    This report provides in-depth spending, staffing and timeline benchmarks to optimize regulatory affairs performance. Complementing the data are leading executives’ strategic recommendations and best practices for overcoming the toughest challenges in the current regulatory environment.


    Boost Team Productivity

    Regulatory affairs groups have never been more vital to company health. Use the report’s year-over-year budget benchmarks and projections to stay competitive as you learn how to attract and retain top talent. Understand outsourcing decisions and the most sought-after skills in regulatory professionals.


    Improve Submission Timelines

    Even as regulatory affairs becomes more dynamic, success boils down to data submission and marketing approval.  Compare timeline metrics across company sizes, and learn to identify and overcome hurdles in your regulatory processes to get products to market as soon as possible.


    Manage the Impact of Globalization

    Harmonization of regulatory policies is happening, but slowly. Implement processes and best practices to stay on top of changing rules and regulations.



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  • Regulatory Affairs Metrics


    Chapter 1: Regulatory Affairs Budgets, Staffing and Outsourcing

     Chapter Benefits

    • Optimize efficiency as workloads increase.

    • Benchmark budgets and staffing to ensure ample resources.

    • Stay current with the latest spending and staffing trends — examine in-depth year-over-year metrics from 2009–2012.

    • Discover leading companies’ best practices to manage employee turnover.

    • Explore how other companies reevaluate their processes to maximize productivity.

    • Leverage and boost expertise without increasing headcount.

    • See how much other companies of your size are outsourcing and what/when they choose to outsource.

    Chapter Data

     43 charts focused on these topics:


    • Average percentage change in regulatory affairs budgets from 2010–2012, by company type (Top 20, Top 50, medical device and small/biotech)
    • Department/source of regulatory affairs group funding
    • Regulatory affairs budgets for 2010, 2011 and 2012 (broken down by Top 20, Top 50, medical device and small/biotech companies)
    • Percentage change in regulatory affairs budget, 2010–2011 and 2011–2012 (Top 20, Top 50 medical device and small/biotech)



    • Percentage of companies that outsource portions of regulatory affairs responsibilities
    • Frequency of contact with outsourced regulatory affairs personnel
    • Percentage of budget outsourced in 2012 (broken down by Top 20, Top 50, medical device and small/biotech companies)



    • Percentage change in total regulatory affairs staffing between 2009 and 2012 (Top 20, Top 50, medical device and small/biotech)
    • Projected percentage change in total regulatory affairs staffing between 2013 and 2015
    • 2012 regulatory affairs staffing metrics (broken down by Top 20, Top 50, small/biotech and medical device firms)


    Chapter 2: Regulatory Affairs Strategy: Structure and Challenges

     Chapter Benefits

    • Empower regulatory affairs and drive strategy through structure.
    • Understand different companies’ approaches to structure — and why centralization is the clear preference.
    • Strengthen communication — especially between headquarters and affiliates — using top-performing companies’ strategies and best practices.
    • Position regulatory affairs at the center of strategic activity by seeing who leads regulatory affairs and which departments the group interacts with or has oversight over.
    • Understand how different factors, including company size and staff experience, impact interaction with the FDA.
    • Identify regulatory affairs’ most pressing challenges — and see how companies work to mitigate them.
    • Streamline activities and shorten timelines with spend/activity data. Identify time- and money-wasters.


     Key Metrics

    42 charts focused on structure, challenges, and timelines:

    • Regulatory affairs structure preferences (e.g., centralized, decentralized by geography, brand or therapeutic area), by percentage
    • Regulatory affairs structure (broken down by Top 20 companies, Top 50, small/biotech, device and other)
    • Departments that regulatory affairs oversees (device and small/biotech companies)
    • Level of executive leading regulatory affairs (Top 20, Top 50, small/biotech companies, device)
    • Age of regulatory affairs function, by company type
    • Group that regulatory affairs teams interact with most frequently (Top 20, Top 50, small/biotech companies and device)
    • Frequency of interaction with FDA representatives (Top 20, Top 50, small/biotech and device)
    • Evaluation of regulatory submission timelines (e.g., increased, decreased or stayed the same), by company type
    • Evaluation of regulatory challenges (i.e., no challenge to significant challenge)
    • Evaluation of most challenging regulatory bodies
    • Percentage of time spent on specific regulatory affairs activities, broken down by regulatory activity
    • Percentage of budget and time spent on specific regulatory affairs activities, for individual surveyed companies


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  • Key Finding from Regulatory Affairs Research

    The following excerpt is a key finding from the full report's executive summary:

    Manage Expectations for Submission Timelines by Adjusting for Company Size and Regulatory Affairs Experience

    Regulatory submission timelines are either longer or shorter than they used to be, depending on who answers the question.  Objectively speaking, the FDA in particular has ushered in new accelerated timelines and shorter submission evaluation windows, meaning that companies should be experiencing expedited review times in the US. Figure E.3 [Figure included in full report] shows large and mid-sized companies’ evaluations of submission timelines compared to small and device companies.

    Interviewed executives from large and small companies painted vastly differing pictures of the regulatory environment. Large companies with large headcounts, experienced personnel and long-standing relationships with regulatory agencies are in position to leverage that relationship toward expedited review times. This is in direct contrast with smaller companies, whose regulatory affairs staffs are significantly smaller and less tenured.  Often these companies are comparatively new to the regulatory playing field, have not built relationships with regulatory agency personnel, and thus do not have a direct, familiar point of contact when trouble arises.

    Moreover, experience matters. A consolidation of regulatory affairs experience within large companies is ongoing, and consequently submissions are streamlining there. Regulatory agencies are not likely to negotiate with regulatory affairs employees over submission issues: either the submission is complete or it is not.  Avoiding such mistakes in the first place — something an experienced FTE is more likely to do — saves critical time and resources on behalf of the submitting company.

    The most important factor contributing to coordination with a regulatory agency is the experience of the regulatory affairs team. A number of surveyed companies point out that experience is becoming a necessity within regulatory affairs groups.  Nowhere is the benefit of experience more evident than when dealing directly with regulatory agencies.

    While a number of smaller companies’ contact with FDA is limited to written correspondence, most large companies with vast experience on their teams report more direct communication with the FDA.

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