How To Develop Regulatory and Product Quality Expertise
My 3rd July article gives you some actionable strategies for knowledge and skill development in drug manufacturing.
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A recent graduate asked me about how to develop regulatory and quality expertise in drug product manufacturing. This is a classic case of you can’t get hired unless you have experience, and you can’t get experience unless you are hired. However, you can increase your chances of landing a relevant or related role through simple preparation. Let’s go over the three easy steps in this article. I’ll speak mainly about the drug product/drug substance case, but these principles apply [with different references] to any medical product (biologics, devices, diagnostics, and digital health).
1. Read
Your first step should be familiarizing yourself with the laws and regulations for drug manufacturing. In the US, this means learning about the Food, Drug, and Cosmetic Act of 1938 and its multiple amendments. [1] This Congressional act authorizes the Food and Drug Administration to oversee the safety of food, drugs, medical devices, and cosmetics. These laws also give the FDA authority to regulate animal drugs and feed and make sure products that emit radiation do no harm. However, laws only provide the broad outlines of authority for an agency. The details are contained in the Code of Federal Regulations (CFR); specifically Title 21 Chapter 1 [2] A quick review of the Subchapter titles will orient you to the organization. Citations are usually given as 21CFR Part #, and Part 210 and 211 are the primary cGMP manufacturing regulations for drugs. I recommend looking over the other section titles and reading any related to your area of interest.
The regulations are still fairly broad, so the FDA issues guidance documents to clarify their thinking on multiple topics. You can find these using the guidance search engine. [3] Search for “CGMP” to retrieve the guidance related to drug manufacturing. Some of these may be from other FDA Centers – you can sort by this and other relevant parameters to refine your list. The FDA’s Inspection References are another goldmine of practical information about inspection conduct and response. [4] Regulatory and quality professionals must routinely address this information in their work. Many of these regulations also cover the quality principles important to product manufacturing.
There are additional regulatory frameworks to review for those planning to work on drugs for non-US markets. The largest non-US markets are in the EU, UK, and Japan. For EU countries, the European Medicines Agency is the primary regulatory body.[5] In the UK, the Medicines & Healthcare Products Regulatory Agency handles both drugs and medical devices.[6] In Japan, the primary regulatory agency for drugs is the Pharmaceuticals and Medical Devices Agency.[7] All three have laws, regulations, and guidance you should be familiar with as a regulatory professional. The International Council on Harmonization (ICH) brings together multiple “regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop new guidelines.”[8]
2. Study
Reviewing the laws, regulations, and guidance only gives you some of the information you need to be a regulatory affairs or quality professional. It’s important to understand how these frameworks are implemented and consider the industry best practices. All of the regulatory authorities provide e-learning, online, and in-person training, as well as discussion opportunities via meetings, conferences and workshops. Examples include the FDA’s Training and Continuing Education website[9] and the EMA’s Eudravigilance training and support website.[10] Some of them provide training documentation useful for inclusion on your resume and a certification requirement (see below).
If you intend to fully engage with industry as a regulatory affairs or quality professional, you may want to consider a certificate or degree from a college or university. I recommend shopping for the best return on your investment, as some of these programs can be quite expensive. Asking about the relative value of these programs while networking, and surveying job postings for credential expectations are good ways to evaluate their reward potential. Keep in mind that holding a position with “regulatory” in the job title or description is more valuable than a degree or credential. This included titles like “Regulatory Associate.” Practical experience remains an effective strategy. Be sure to evaluate training and temporary assignment options available within your current company, too.
Lastly, there are two professional organizations offering training and credentialing programs for the industry. These are the Regulatory Affairs Professionals Society (RAPS) [11] and the American Society for Quality.[12] Membership in both is surprisingly reasonable and comes with a host of benefits, including free education and training, access to chapters & local networks, and discounted professional conferences and resources. Check to see if your company has an enterprise membership you can access. Their certifications are all highly regarded by industry and regulatory authorities. It’s my experience that you can study and complete certifications without taking a formal program. Both also have programs for early career professionals to gain certification without formal degree work or experience.
3. Engage
It’s my experience that regulatory affairs professionals are eager to share their knowledge and love of the career path with others. That means networking is a fantastic way to learn more about the career path, your options to start and advance, and to gather specific expertise in focus areas. Start with the RAPS chapter in your area, because they will likely have low-cost events. There are other professional societies where you can find aligned professionals and expand your professional network. Some of them also offer education, training, and certifications to develop specialized competencies. Some examples include the Society for Sterility Assurance Professionals[13] and the Parenteral Drug Association.[14]
Consider engaging and networking outside of regulatory- or quality-focused groups, too. One of the most relevant and accessible organizations in this space is the Healthcare Businesswomen’s Association.[15] Open to emerging professionals, c-suite executives, corporate board members, and entrepreneurs of all genders, the HBA leads on the mission of advancing the impact of women in healthcare across all career tracks. Membership is an excellent way to meet and ask questions of professionals at all career stages. Local organization abound in areas where the practice of regulatory affairs is common.[16] Engaging with professional societies is among the best way to collect the finer details on navigating a career path.
The Take-Home Message
You have multiple options available to learn more about the practice of quality and regulatory affairs in developing drug substances and products. Many of these are available at no or low-cost. The regulatory and clinical affairs career path is readily pursued due to the shortage of trained professionals. The regulatory professionals I know are eager to share their work with others, so networking is an excellent place to start exploring your options.
Legitimate questions are being raised about how changes in the U.S. Administration during 2025-2028 will affect the practice of regulatory affairs. RAPS is already engaging in productive discussion via workshops.[17] Regulatory and quality science are important to ensure public safety and confidence in new medical products. Consistent with common industry ethical standards, I expect more professional engagement with national and international leaders to craft a knowledge- and experience-based path forward.
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References
[1] FDA.gov website, “Laws Enforced by FDA.” Accessed January 27, 2025. https://www.fda.gov/regulatory-information/laws-enforced-fda
[2] National Archives website, “Code of Federal Regulations: a point in time eCFR system,” Title 21. Accessed January 27, 2025. https://www.ecfr.gov/current/title-21
[3] FDA.gov website, “Search for FDA Guidance Documents.” Accessed January 27, 2025.
[4] FDA.gov website, “Inspection References.” Accessed January 27, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references
[5] European Medicines Agency (EMA) website. Accessed March 3, 2025. https://www.ema.europa.eu/en/homepage
[6] Medicines & Healthcare Products Regulatory Agency (MHRA) website. Accessed March 3, 2025. https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
[7] Pharmaceuticals and Medical Devices Agency (PMDA) website. Accessed March 3, 2025. https://www.pmda.go.jp/english/
[8] International Council for Harmonisation (ICH) website. Accessed March 3, 2025. https://www.ich.org
[9] FDA.gov website, “Training and Continuing Education.” Accessed March 3, 2025. https://www.fda.gov/training-and-continuing-education
[10] EMA.europa.eu website, “Eudravigilance training and support.” Accessed March 3, 2025. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance/eudravigilance-training-support
[11] Regulatory Affairs Professionals Society website. Accessed March 3, 2025. https://www.raps.org
[12] American Society for Quality (ASQ) website. Accessed March 3, 2025. https://asq.org
[13] Society for Sterility Assurance Professionals (SfSAP) website. Accessed March 3, 2025. https://sfsap.org
[14] Parenteral Drug Association (PDA) website. Accessed March 3, 2025. https://www.pda.org
[15] Healthcare Businesswomen’s Association (HBA) website. Accessed March 3, 2025. https://hbanet.org
[16] An example is the Organization of Regulatory and Clinical Associates (ORCA) in Washington State. Website accessed March 3, 2025. https://orcanw.org
[17] RAPS.org website, “RAPS Workshop: Survivor: The FDA 510(k) Program Edition (March 2025).” Accessed March 3, 2025. https://www.raps.org/events/raps-workshop-survivor-the-fda-510k-program-edition-march-2025
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