The Changing Role of Regulatory Professionals

Feature ArticlesFeature Articles | 28 February 2020 | Citation

Regulatory Focus has brought together a diverse group of experts to address today’s most pressing issues for regulatory professionals on communication methods to employ with various stakeholders regarding why regulatory is important. Global experts provided insight and shared their experiences on the importance of regulatory affairs to key company decision makers, including what regulatory can do for all stakeholders, demonstrating regulatory value and writing informed consent documents. Other articles tackled the evolving role of regulatory operations professionals and the need for building interorganizational relationships.
The Expanding Importance of Regulatory
 “How much will it cost?” is one of the first questions asked by company stakeholders when the topic of regulatory needs comes up. This question is typically followed by “How long will it take?” Legal expert, Elina Khachiyan, addresses these questions and more in “Communicating the Importance of Regulatory to Various Stakeholders.” She focuses on the importance of a strong regulatory compliant culture within an organization and proclaims that, without the support and involvement of various stakeholders, it is impossible to reach and maintain this culture. She also explains how regulatory professionals can effectively communicate the importance of regulatory to help the organization meet its goals.
In the current economic environment, biopharmaceutical sponsors are being asked to achieve more with fewer resources. In “Demonstrating Regulatory Value, ” the critical role of regulatory is highlighted in terms of its contribution to cost savings and eventual product earnings. Director of regulatory affairs, Aurora Sosa, demonstrates how regulatory not only provides operational support in terms of the submission preparations and providing the administrative role with US FDA, but also explains how the role strategically contributes to the clinical development of a drug product.
The life science industry is one of the most heavily regulated industries and executives, senior managers and investors must understand how different decisions about a product can impact its regulatory path and, ultimately, commercialization. “Why Understanding Regulatory Affairs is Important to key Company Decision Makers” discusses the reasons why continuous evaluation of the regulatory framework is important for company decision makers and how companies can benefit from making efforts to understand the regulatory landscape for their product. Regulatory consultant, Isabella Schmitt, explains how the decision framework may change depending on where the product is within the lifecycle of development and emphasizes pivotal decisions such as target indications, intended use claims and different marketplaces and how an understanding of the regulatory requirements of these items can facilitate decision making.
Evolving Regulatory Landscape
In a constantly changing global regulatory environment, explaining what you, as a regulatory professional, do for a living can be a difficult since regulatory professionals must be involved at every phase of developing, marketing and selling a product. Senior regulatory consultant, Adriana Becker, discusses the ever-widening range of responsibility for regulatory professionals and the increasing importance of their role to an organization’s “bottom line.” “The Changing Role of the Regulatory Professional” covers the value of continuously developing new skills in addition to regulatory and scientific knowledge to more effectively interface with colleagues who have a variety of expertise. She highlights the effects of increased regulatory scrutiny, such as through compliance with the European Union’s new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) and emphasizes the benefits of developing good writing skills.
As novel therapy development increases, regulatory standards evolve and technology plays an increasingly more important role in the management of regulatory information, regulatory operations professionals face a much different world than the one they faced 10 years ago. In “How the Role of Regulatory Operations Professionals Will Evolve in the new Decade,” global regulatory strategist, Rachel Belani introduces forward-looking trends potentially affecting how the role of regulatory operations professionals will progress over the next decade. Regulatory operations professionals from three biopharmaceutical companies also share their perspectives on the changing regulatory landscape and emerging challenges.
Is there really a difference between legal and regulatory in Promotional Review Committee (PRC) meetings? Legal expert, Alicia Whittlesey, tackles this important question in “Regulatory and Legal Roles in Promotional Review Committee Meetings.” She provides perspectives on how legal and regulatory personnel and others view their roles when participating in promotional and other types of material reviews.  She also defines and separates the roles and provides results from an informal survey regarding what people in the industry think about the nature of the two roles in reference to promotional reviews. She concludes by suggesting that moving the company forward in a compliant way should be everyone’s goal.
Communication is Key to Clinical Trials Recruitment
An informed consent document is required to help people decide whether or not to participate in a clinical trial. Medical writing expert, Viji Ramesh, describes the best practices used to develop informed consent documents, including skillful writing to communicate the objectives, benefits, implications, risks and inconveniences of participating in the clinical trial, as well as the rights as clinical trial participants. “Writing Informed Consent Documents: A Balancing Act” covers the important aspects a medical writer can contribute to developing a strong and easily understandable informed consent, including paying particular attention to using plain language, making the document readable, being aware of potential social and cultural issues, avoiding scientific, legal or medical jargon and information overload.
What you May Have Missed at Convergence

Two regulatory experts, Jennifer Weidman and Kimberly Belsky, discuss how to estimate the probability of regulatory/registration success for pharmaceutical products in development in “Estimating the Probability of Regulatory Registration Success.” Based on their presentation at RAPS Regulatory Convergence in September 2019, the experts define the factors and methods used to assess regulatory/registration success and offer objective and data-driven methods to define probabilities for the purposes of documenting specific factors and/or risks relative to a likelihood of success. They provide a case study demonstrating how to use data and make estimate adjustments based on a variety of factors specific to individual programs.
What’s ahead at EURO Convergence?

Regulatory and legal experts, Ludger Möller and Erik Vollebregt, share their views on the European Union’s revised Medical Devices Regulation (MDR) and the EU’s requirements for Economic Operators (EOs) to play major roles in medical device authorizations and postauthorization monitoring. Their article, “Economic Operators: Roles and Obligations Under EU’s MDR,” was based on an upcoming presentation at RAPS Euro Convergence, 11-13 May 2020 in Brussels, Belgium. The experts highlight roles and responsibilities for Manufacturers, Authorized Representatives, Importers and Distributors (MAID) for assuring compliance with new EU MDR in addition to public health/patient safety goals.
What’s coming in March?

Regulatory Focus has lined up some top experts to share their views on regulatory ethics in the current environment. Individual topics will include professionalism and integrity and how ethics can impact drug master files, listing of facilities and the drug supply chain. Other key focus areas will include the progression of regulatory intelligence and strategy to foster the evolving landscape, how the role of regulatory operations professionals will evolve and understanding regulatory operations and the eCTD submission process for effective communication with health authorities. Look for these and other topics throughout March.
Just Released: Your Latest RAPS Member Benefit is Here
Regulatory Focus tackles the transformation and changing role of regulatory professionals occurring globally in all organizations in its latest electronic article series “The Strategic Role of the Regulatory Professional.”
This edition brings together some of the top regulatory influencers from around the world—all with diverse experience—and offers their perspectives on how the shifting landscape and evolving regulatory approaches are impacting the regulatory profession today. With the need of regulatory science to keep pace with the changing global landscape, technological advancements, increased innovation and the complexity of the drug and device development process, the role of the regulatory professional has become ever more strategic. This insightful collection of articles illustrates the expanding strategic role of regulatory professionals and demonstrates the vital role regulatory plays within organizations and throughout the product lifecycle.
RAPS Regulatory Focus Tackles Risk Management in May

Quality risk management is a key component and a “must have” requirement for a compliant quality system. In regulatory affairs, risk management is particularly important when selecting suppliers and service providers. These third parties can have a fundamental effect on the validity and compliance of data, systems and operational processes. Articles for May should provide best practices on how risks are addressed and managed. Individual articles and case studies could address:
  • data and records management system suppliers and hosts for (pharmaco)vigilance or for adverse events reporting
  • third party affiliates, agents or representatives
  • outsourced regulatory functions for legacy products
  • contracted interim regulatory managers
The submission deadline for May is 6 April. If you are interested in contributing to May or another month, please contact for the 2020 editorial calendar, deadlines and author guidelines.

Cite as: Hall G. “The Changing Role of Regulatory Professionals.” Regulatory Focus. March 2020. Regulatory Affairs Professionals Society


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