Pharmaceutical Regulatory Affairs (PH194)

Arming Regulatory Groups with Voice and Influence to Meet Strategic Challenges 

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Published 2014
81 Pages
400+ Metrics
50 Charts and Diagrams

Get the Latest Analysis of Evolving Regulatory Trends

The role of regulatory affairs is evolving, and companies need these groups to have greater strategic impact on product development.  Regulatory affairs’ knowledge impacts trial designs, ensures submission success and keeps products on the market.  But regulatory affairs’ strategic role requires increasing cross-functional communication.  Unfortunately, other functions’ perceptions of regulatory affairs may be outdated, inaccurate and potentially harmful to product development and market access.

The findings in this report were developed through extensive surveys and qualitative interviews with regulatory affairs executives at more than 20 pharmaceutical, biotechnology and medical device companies.  The insights contained within will empower regulatory affairs groups to interact with key stakeholders and influence product development, as well as allow them to achieve the optimal balance of responsibilities between centralized global groups and country-level teams.  Furthermore, the report’s key recommendations focus on how drug and device manufacturers can solidify two-way relationships with regulatory agencies — helping to guarantee product approval and optimal reimbursement status.

Communication with regulators is crucial as each market’s requirements get more complex.  Developing strategies to understand an agency’s unique requirements is crucial to smooth submissions and approval.   But companies need to properly organize their regulatory teams to achieve these goals.  They also need to educate internal groups companywide on regulatory requirements and regulatory affairs groups’ responsibilities. This study is the roadmap that regulatory affairs teams can use to overcome these challenges.

Key Questions that This Study Answers

  1. Which individual countries present difficult regulatory environments and what strategies do companies employ to overcome those challenges?
  2. What is the average regulatory affairs budget and what are some internal sources of funding that other companies use to support their regulatory teams?
  3. What are other companies’ best practices for streamlining ever-increasing regulatory workloads?
  4. At which points throughout the product lifecycle should different internal groups work with the regulatory affairs team?
  5. Why is it important to involve regulatory throughout the product lifecycle?

Top Reasons to Review This Report

Build stronger relationships with regulatory agencies to ensure successful submissions: Encouraging open communication with regulatory agencies involves focusing on internal training and regularly communicating with government organizations early in the development process. Use this report to learn agencies’ unique communication preferences and requirements to effectively maintain relationships.  Furthermore, study how other companies develop core strategies and best practices to face challenges in different markets.

Establish a dedicated regulatory affairs budget to enable greater flexibility: Due to the increasing costs of compliance and regulatory activities, many companies are dedicating larger regulatory affairs budgets year after year.  Examine budget breakdowns for both global- and country-level regulatory groups, including analysis on how those funds are allocated for technology, travel, overhead, outsourcing and other regulatory activities.

Increase cross-functional communication between regulatory, development and commercialization teams:  Some companies’ regulatory affairs teams struggle with other functions’ lack of regulatory knowledge.  The findings in this report will help regulatory managers increase communication between teams and better educate other groups of regulatory requirements.  Read about how other companies integrate regulatory strategy into trial design to yield satisfactory data for relevant agencies.

Pharmaceutical Regulatory Affairs Metrics

Chapter 1: Strengthening Regulatory Affairs' Internal Impact

Chapter Benefits

  • Leverage regulatory intelligence to stay updated on the ever-changing environment and determine how new requirements will affect the company.
  • Involve regulatory strategy, from early in clinical phases through post-approval, to ensure the product reaches the market and stays there.
  • Coordinate cross-functional meetings involving regulatory affairs to integrate regulatory strategy into product development.
  • Gain internal allies by educating other functions regarding regulatory requirements and processes.
  • Communicate regulatory needs and concerns with senior-level global individuals.

Chapter Data

23 charts focused on meeting type (formal vs. informal), level of executive interacting with regulatory groups and ratings of communication with internal teams.  Data are broken down into global and country-level teams.

  • Importance of regulatory intelligence function
  • Number of formal and informal meetings with specific functions per month, by department and company
    • Marketing/commercial
    • Clinical/R&D
    • Medical affairs
  • Level of executive interacting with regulatory teams, by position
  • Success ratings of communications, by function and region (marketing/commercial, clinical/R&D, medical affairs)

Chapter 2: Working Effectively with Regulatory Agencies

Chapter Benefits

  • Understand key differences among agencies to address agency priorities and best position products for different markets.
  • Boil down complex scientific data as needed to effectively communicate with agency personnel.
  • Consider third-party subject matter experts to communicate key points to agencies.
  • Adjust to lag between the time when certain practices become de facto requirements and when formal guidance is published.
  • Balance formal and informal communication to build relationships and understand agency needs.
  • Maintain the regulatory staff and intelligence resources to manage regulations that only get more complex.
  • Coordinate submission efforts between centralized and local teams.

Chapter Data

6 charts detailing challenging markets for regulatory affairs teams; and number of formal/informal meetings between companies and regulatory agencies.  Data are broken down into global and country-level teams.

  • Markets most commonly perceived as a challenge for regulatory affairs, by region (global and country-level)
  • Number of formal meetings between company and regulatory agency, by phase, product
  • Number of informal meetings between company and regulatory agency, by phase, product

Chapter 3: Regulatory Affairs Management Benchmarks

Chapter Benefits

  • Organize regulatory affairs groups around an effective central hub.
  • Balance between global and country-level teams to address both key centralized tasks and support for countries.

Chapter Data

19 charts detailing regulatory affairs budget and staffing for global and country-level regulatory affairs teams:

    • Real-company diagrams of regulatory affairs structures
    • Number of FTEs within regulatory affairs in 2013, by company
    • Expected change in number of FTEs within regulatory affairs, by company
    • Sources of funding for regulatory affairs
    • Allocation of funds within regulatory affairs
    • Activities supported by regulatory affairs, by function:
      • Clinical
      • Market-oriented
      • Manufacturing

Pharmaceutical Regulatory Affairs Report Sample


The following is a finding excerpted from the full report's first chapter:

Involve Regulatory Affairs Early in a Product's Lifecycle

For regulatory affairs to maximize its strategic impact on a product’s development, it needs to be involved in the early stages of a product’s lifecycle. The regulatory affairs group at Company B, for example, offers input to R&D and other product development groups about a year before investigational new drug (IND) application preparations. From this early stage, regulatory affairs groups can help shape the target product profile (TPP) alongside commercial and clinical groups. At Company B, commercial groups are responsible for the TPP, but clinical and regulatory affairs help to develop it.

Regulatory affairs team input is necessary during these early phases because every step a company makes leading up to submission can affect whether or not the regulatory agency approves the drug. Specifically, regulatory should be involved in clinical trial study designs. As a director at Company E explained, “The onus is on the company to bring the data to an agency and explain to them why they are adequate to show safety and efficacy. If you do not convince them of that, then the product is not on the market.” A company’s regulatory affairs function should also be involved early in product development to ensure that the clinical studies are designed to produce satisfactory data to the regulatory agency. In essence, regulatory affairs aims to predict and avoid potential problems the regulatory agency may have with the product before the company submits documentation to the agency.

To ensure that its drug follows current requirements, Company B’s regulatory affairs group gets heavily involved in product development planning beginning with pre-IND discussions. As the senior VP of regulatory affairs explained, “We’re pretty embedded with the team from early day one, and that’s the way that you really add value.”