This article is part of our Summer Webinar Series

In the past 100 years, the regulatory landscape has transformed from virtually nonexistent to a highly-regulated and complex industry. This transformation can be attributed to a wide range of factors including: the need for governments to protect the public, the successes of the biopharmaceutical industry in delivering medications, as well as the failures of products released, and new advancements in medical technologies. These and many more factors result in the watchful eye and ever-changing expectations of health authorities.

This change initially invented and now increases the demand for regulatory affairs professionals. Companies rely on their regulatory affairs groups to be knowledgeable of dynamic health authority standards worldwide, ensure product compliancy and, play a central role with other functions internally, while simultaneously seeking and strategizing opportunities in the highly regulated and complex industry.

Regulatory affairs professionals work across the entire spectrum of development, manufacturing, registration, post-marketing activities, and lifecycle optimizations. Their role is not limited simply to bringing a drug to market, but spans from far before product registration and continues beyond market launch. As a result, regulatory professionals wear many hats and are expected to play many roles as a critical business partner to strategic partners. Regulatory affairs is broken down into further functional units, each requiring a unique skill set and fulfilling a different business need. These units include product development, policy and regulatory intelligence, advertising and promotion, and chemistry, manufacturing, and controls (CMC).

Those working within Product Development focus on the creation of a global regulatory strategy and engage with health authorities related to product development and registration. The Policy and Regulatory Intelligence group reports trends in the regulatory landscape, develops company policies and positions according to health authority guidance and standards, and seek intel by analyzing precedents and company approvals. In Advertising and Promotion, the regulatory professional works diligently with marketing, medical, and legal teams to ensure competitive, yet compliant materials. The CMC group is responsible for honing in on all items related to the manufacturing of the product, such as good manufacturing practices (GMP) compliance or facility and site inspections.

How these units are organized and their exact requirements may vary from company to company. Their goals however remain the same: to bring forth innovative regulatory strategies for product development by proactively contributing to the company’s success and forging relationships cross-functionally and with health authorities to facilitate collaboration that helps lead to product success. Pharmacists can play a role in of the units aforementioned, with the appropriate training, qualities, and drive. Pharmacists already have the clinical background, the patient-provider perspective, and the ability to work in teams that are necessary to work in regulatory affairs groups.


Headshot of Afeefa BhattiAfeefa Bhatti, PharmD, is a Global Regulatory Affairs Post-Doctoral Fellow with MCPHS University and Sanofi Genzyme

 

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