Job Demands Understanding of Regulatory Affairs

Suzette Nubie has more than 21 years of professional experience working in the biotech and pharmaceutical industry.

During her tenure, Suzette has worked in both quality control and quality assurance. While her knowledge runs deep in those departments, Suzette had minimal interactions with the regulatory affairs division—critical to the successful market launch of any biotech or biopharma product.

It was this lack of knowledge of a critical component that spurred Suzette to complete the Professional Program in Regulatory Affairs.

“In 2014, I began working at a small biotech company that was in the process of obtaining regulatory (FDA) approval,” Suzette recalls. “I was a Senior Manager QA Commercial and had oversight of our contract manufacturers, which included being the QA-designated subject-matter expert for commercial products. I managed QA activities related to commercial product compliance and operations. My duties included assurance of commercial product quality, oversight of exceptions, and ensuring timely and meaningful resolution of potential quality issues that affect the commercial products.”

Key to performing those duties to her satisfaction: understanding the role that regulatory affairs plays in securing that FDA approval.

I was definitely able to apply my classroom learning and knowledge at work.

Instructors’ Depth of Knowledge Parlayed Into Real-World Cases

While the curriculum provided her with a sturdy base of knowledge, it was the interactions with her instructors that proved most beneficial—specifically, those with Kristi Miller, Linda Yang, Donna Kato and Ron Carlson.

“If I had questions specific to license applications, I could email the instructor and receive a response with the possibility to discuss further. For example, I would ask, ‘What information is included in an IND?’ ‘If there is a critical deviation during the manufacturing of a drug substance, is the deviation included in the IND?’ ‘If yes, what section?’

“I was definitely able to apply my classroom learning and knowledge at work—if not the next day, then when I needed that information,” Suzette recalls.”

My long-term goal is to transition to regulatory affairs one day, and this is the first step.

Knowledge Base There When She Needs It

Today, Suzette is working at Intarcia Therapeutics Inc. as Senior Manager of the Quality Assurance Systems group, which handles deviations, corrective and preventive actions (CAPAs) and change controls. Her typical workweek includes performing quality review and approval of root-cause investigations and corrective and preventive actions.

The company is currently undergoing the approval process with the FDA and is fully staffed in the regulatory affairs department. While Suzette is not fully employing her regulatory affairs education in her day-to-day operations, she now has a base of knowledge to better understand her colleagues’ roles and better communicate using industry jargon.

“Professionally, having this certificate on my résumé looks great and is definitely value-added to my industry,” Suzette enthuses. “Personally, I have accomplished a goal while working full-time, which is huge! To take the time—primarily on Saturdays—and complete the work is fulfilling. My long-term goal is to transition to regulatory affairs one day, and this is the first step.”