Understanding the Why of Regulatory Frameworks
A research associate position in A.T. Still University’s microbiology and immunology department would be Mike Blaine’s catalyst for the science career that would follow. As a microbiology/immunology research associate for the university, Mike worked closely with Dr. Neil Sargentini and Deborah Hudman—department chair and research manager, respectively—who he credits with shaping his early professional development in ways that have stayed with him throughout his career and would eventually lead him to become a graduate of our Professional Program in Regulatory Affairs—nearly 10 years after that role.
“I gained invaluable experience revising and writing standard operating procedures, crafting research proposals, and even teaching medical and dental students during their laboratory sessions,” he says. “I also had the opportunity to work on every aspect of a study, from pouring sterile agar into petri dishes and culturing microbes, to operating UV and radiation equipment, conducting microscopy and writing scientific reports.
“This hands-on experience gave me a deep appreciation for working with microorganisms, those tiny specimens visible only under a microscope,” he continues. “It was in this role that I truly fell in love with the precision and discovery inherent in laboratory work.”
Mike—who grew up in Livingston, Calif., and was raised by a resilient, single mother with the steadfast support of his grandparents—had originally thought that attending college was an unattainable goal. But while he self-proclaims to not have been the most naturally studious person, he did have a deep fascination with science growing up, captivated by shows like Bill Nye the Science Guy and MythBusters, which made the world of science and experimentation feel both magical and accessible.
“A pivotal moment came during a class field trip to UC Davis, where I was introduced to the university's renowned biological sciences and agricultural programs,” Mike says. “It was eye-opening to see a place so deeply committed to innovation and discovery.”
He applied to and was accepted to UC Davis, earning his bachelor’s degree in biological sciences and on his way to realizing his dreams. Being at a top agricultural school, Mike was eager to get hands-on experience in research and landed a plant sciences laboratory assistant position. This role not only gave him invaluable experience, but also taught him the importance of stepping outside of his comfort zone.
Furthering His Education and Life Skills
Profoundly impacted by the events of September 11 when he was in high school, Mike’s sense of duty led him to take a few ROTC electives while earning his undergrad. After graduation, Mike fulfilled a life goal by joining the armed services as a cryptologic linguist.
“In my final year, I decided to follow that call to serve and enlist in the U.S. Army, specifically in the intelligence community,” he says. The life-changing decision also strengthened his ability to concentrate in high-pressure situations with accuracy and care.
“I trained in the Persian-Farsi language at the Defense Language Institute Foreign Language Center in Monterey, California, and worked on decoding and analyzing critical information—an experience that sharpened my ability to focus, problem-solve under pressure and execute tasks with precision.
“My time in the military also taught me invaluable leadership skills and resilience,” he adds, “all of which have carried over into my career and life goals, especially in science and regulatory roles.”
After serving, he secured that previously mentioned staff position at A.T. Still University, where his wife was attending medical school. Encouraged to keep striving to learn more, Mike earned a master's degree in biotechnology from University of Maryland Global Campus (UMGC). It was during his course on commercializing biotechnology that ignited an interest in combining biology with business.
“That spark grew as I completed an assignment requiring me to read research articles and develop a condensed business plan,” Mike tells me. “One article in particular—discussing a global shortage of reproductive tissue, declining male fertility and innovative solutions like motorized ‘spermbots’—fascinated me. I wrote a business plan based on addressing these issues, which eventually evolved into a comprehensive proposal.”
To deepen his understanding of business principles and how they could complement his science background, Mike pursued an M.B.A., also at UMGC. With the support of the U.S. Small Business Administration, he turned that business plan into reality, co-founding Cryobank America, LLC, in Arlington, Texas, and becoming the startup’s chief financial officer.
“This venture allowed me to apply everything I had learned—from leading the company’s financial operations, to managing quality and ensuring regulatory compliance during Food and Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA) inspections,” he explains. “It was a unique opportunity to merge my scientific knowledge and business acumen to create a meaningful impact in a growing field.”
While working tirelessly to ensure the success of his startup, Mike also had to bridge the gap and meet personal financial obligations, which he did as manager of quality operations for WP Pharma Labs, a national 503A compounding pharmacy.
“This role not only provided personal financial stability but also turned out to be invaluable in furthering my expertise in quality assurance and regulatory compliance,” he says. The hands-on experience and skills Mike gained working in cleanroom environments and implementing good pharmaceutical practices (GPP) and good manufacturing practices (GMP) directly influenced how he enhanced and strengthened the standard operating procedures and quality measures at his own company.
However, he notes, “Perhaps most impactful was the opportunity to host regulatory inspections by bodies like state boards of pharmacy. While these inspections were often stressful, they were equally educational. The detailed questioning and discussions forced me to think critically about the why behind each rule or process, emphasizing their role in ensuring compliance and, most importantly, the safety, efficacy and quality of the finished product for customers. This experience deepened my respect for regulatory affairs and sparked my desire to enhance my knowledge further in this critical field.”
“I wanted to build skills that I could immediately use in my career to make a tangible impact.”
A Greater Appreciation of Regulatory Standards
Back when Mike was studying biological sciences and biotechnology, he hadn’t considered regulatory affairs as part of a potential career—even though he knew what mattered was finding a path where he could make a meaningful impact on others. So it isn’t such a surprise that within three years of working in quality assurance, Mike looked into our Professional Program in Regulatory Affairs to further his education in this area.
“First and foremost, UC Berkeley is renowned as one of the top public universities in the world, and I knew the UC Berkeley Extension program would uphold the academic rigor and excellence associated with the institution,” Mike commends. “The curriculum was comprehensive, covering everything from regulatory compliance to product lifecycle management, and it was clear that the instructors brought an impressive level of expertise and real-world experience to their classes.
“What also stood out to me was how the program emphasizes practical, applicable knowledge. I didn’t want just a theoretical understanding of regulatory affairs—I wanted to build skills that I could immediately use in my career to make a tangible impact. This program offered exactly that, alongside the flexibility that I needed to balance my education with other commitments.
“Choosing UC Berkeley Extension was about aligning myself with a program that matched my goals: refine my skills, broaden my expertise and prepare myself to excel in a field that demands precision, adaptability and a commitment to quality and compliance. It was a natural next step in my journey of continuous learning and professional growth.”
Mike says that each course had a profound impact on his career by providing invaluable insights into bridging the gap between industry and regulatory bodies. They deepened his understanding of how compliance, safety and efficacy intersect with the practical realities of product development and commercialization.
“Of all the courses, Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices was perhaps the most impactful,” he adds. “Dr. Natalie McClure, who was the course instructor, introduced a perspective I had never explored before—the historical context behind the formation of the FDA and the unfortunate events that necessitated its creation. Learning about the tragedies that spurred regulatory oversight, such as the Elixir Sulfanilamide poisoning of 1937 and the Thalidomide crisis, was eye-opening. It provided a deeper appreciation for why these regulations exist and the critical role they play in protecting public health.
“Dr. McClure combined historical narratives with practical, real-world applications that helped us understand not just the how but also the why of regulatory frameworks. For example, during a lecture on regulatory considerations, she introduced us to the tools the FDA employs to ensure compliance with federal regulations—Warning Letters, Form 483s and the mechanisms of inspections. She didn’t just describe these tools; she gave us case studies and real examples of how they’ve been applied, sparking meaningful discussions about compliance strategies and lessons learned from industry missteps.”
Mike also considered CMC Regulatory Compliance for Pharmaceutical Products to be another standout course.
“This course provided a comprehensive overview of chemistry, manufacturing and controls, which is such a critical component of regulatory submissions,” he relates. “Instructor Shelley Suggett emphasized the importance of consistency and traceability in manufacturing processes and helped us develop a keen understanding of how to approach challenges like stability testing and process validation. These are concepts I’ve directly applied in my work—especially during FDA inspections—where these elements are often under scrutiny.
“What made these courses truly impactful wasn’t just the content,” Mike continues, “but how the instructors fostered engagement and critical thinking. They encouraged us to think like regulators—anticipating questions, identifying gaps and ensuring our decisions were always grounded in science and compliance. The blend of historical context, technical knowledge and real-world application has shaped how I approach my work and the way I solve complex regulatory challenges.”
Shortly after completing our Professional Program in Regulatory Affairs, Mike took his new knowledge and skills one step further: He joined the FDA as an investigator.
“During my final course, instructor Dan Klassen mentioned the need for additional FDA investigators and noted that many of his colleagues had transitioned into roles within the agency,” he explains. “His comment intrigued me; I had extensive experience interacting with FDA investigators during audits and inspections but had never considered what it might take to join their team.”
The new opportunity immediately resonated with Mike. Just as his military background instilled a strong sense of duty and service, this role felt like a natural progression of his career—a chance to apply his industry knowledge to a position that directly supported public health. Working on the other side of the regulatory process, ensuring compliance and protecting the public, was both challenging and rewarding.
“Joining the FDA allowed me to further deepen my understanding of regulatory frameworks while contributing to the critical mission of ensuring the safety, efficacy and quality of products that affect so many lives,” he concurs.
“What made these courses truly impactful wasn’t just the content but how the instructors fostered engagement and critical thinking. They encouraged us to think like regulators.”
“Thanks to the education I received in the regulatory affairs program, I was able to step into my role as an FDA investigator with a strong foundation. The curriculum mirrored many aspects of the FDA’s own training—particularly in understanding the agency’s history, critical regulatory milestones and the core principles of the investigational process. This alignment allowed me to hit the ground running and make an impact during my very first inspection.”
How so?
“For example, during my studies,” Mike explains, “I learned about the historical events that shaped the regulatory space and the key elements regulatory agencies prioritize during investigations. This gave me a sense of confidence when writing inspectional reports, engaging with executive management at the firms I inspected and identifying areas for improvement in compliance. I could approach my work with a deeper understanding of why certain processes and controls were necessary to ensure public safety.
“Without the Berkeley program, I don’t believe I would have felt as comfortable or prepared stepping into such a critical role. It bridged the gap between my prior industry experience and the specialized skills required to succeed as an FDA Investigator, equipping me with the tools to thrive in this challenging yet rewarding position.”
Well-Rounded Regulatory Know-How for Greater Success
After a year-long role in the FDA, Mike went back to the private sector to join OptioRx, a private pharmaceutical services company, as their director of quality and compliance. Here, he oversees all aspects of quality assurance and compliance across their U.S. network of pharmacies, including writing and revising standard operating procedures, preparing quality reports, collaborating with third-party testing laboratories, and addressing a wide range of regulatory and operational challenges.
He believes that the education he received from us is what continues to set him up for success.
“I regularly find myself revisiting the lectures, notes and case studies from my time in the program to guide my decision-making and identify the best course of action,” Mike states. “Whether I’m addressing compliance gaps, implementing corrective and preventive action plans (CAPAs) or developing quality metrics, the program has given me a strong framework to ensure our processes meet the highest standards of safety and efficacy.
“In particular, the program’s emphasis on regulatory compliance, quality management systems and post-approval activities has been invaluable. It taught me not only the technical aspects of compliance but also the importance of fostering a culture of quality within an organization. By combining what I learned in the program with my professional background, I’ve been able to design, implement and continuously improve a robust quality management system, while promoting a proactive compliance culture throughout the company.
“The lessons remain a practical and indispensable part of my toolkit, allowing me to approach challenges with confidence and ensure we consistently deliver safe, high-quality products to our customers.”
Evolving With the Future of the Industry
New pharmaceutical products are being developed all the time and those managing the process need to be able to adapt and learn as the regulatory affairs field changes.
Mike found that our program’s emphasis on real-world applications and its alignment with regulatory expectations provided an exceptional foundation that offered both the technical knowledge and practical skills needed to navigate this evolving industry. And he says the industry has already been seeing significant growth and evolution over the years, much of it for the better. Notable changes include updates to U.S. Pharmacopeia (USP) standards.
“One of the most exciting aspects of working in regulatory affairs is that the field is never static—rules, regulations and best practices are always evolving. Staying abreast of regulatory agencies' current thinking and anticipating the direction the industry is heading keeps the work dynamic and engaging. It requires constant learning, adapting and problem-solving, which ensures that no two days are ever the same. This ever-changing landscape encourages professionals like myself to continually grow and refine their skills, preventing stagnation and promoting innovation.”
Looking ahead, Mike believes the field of regulatory affairs will continue to evolve in ways that challenge us to think critically and adapt. “Advancements in technology are likely to play a larger role in compliance monitoring and regulatory submissions,” he predicts, “and increased globalization will necessitate greater harmonization of regulatory requirements across countries, requiring professionals to navigate more complex international frameworks.”
He believes our Professional Program in Regulatory Affairs will prepare those in or wanting to be in this science-related field for these inevitable changes and challenges.
“Throughout my career, stepping outside my comfort zone—whether applying for roles I thought were beyond my reach, founding a company or joining the FDA—has led to opportunities I never thought possible,” Mike tells me.
“For students considering this program, my advice is simple: Be bold and embrace every opportunity to grow. Engage deeply with the material, treat each lecture as a step toward your goals, and know that this program equips you to succeed in a challenging and rewarding field where you can make a meaningful difference.”
