Chemist Transitions to Career in Regulatory Affairs with Help of SDSU Master’s Degree

By Suzana Norberg March 16, 2018

Educated in Europe — Germany, the UK, and Switzerland — Nicole Hilgraf came to the United States in 2001 with a Ph.D. in chemistry to conduct post-doctoral studies at the Scripps Research Institute in La Jolla.

“San Diego was one of the fastest growing biotech hubs at that time, and I decided to stay and joined Vertex Pharmaceuticals as a medicinal chemist,” said Hilgraf. “During my 12-year tenure as a scientist at Vertex, I learned a lot about small-molecule drug discovery and was fortunate to see compounds advance from the original screening hit all the way to drug approval (Kalydeco and Orkambi for cystic fibrosis, and Telaprevir for HCV). I also learned how to successfully manage and lead chemistry teams and how to efficiently work within multidisciplinary team environments.”

By 2014, she wanted to become more involved in the later-stage drug development process, but transferring  within Vertex wasn’t an option, since the San Diego site is involved only in drug discovery.

“I was attracted to regulatory affairs, as this discipline brings together all aspects of drug development, requiring both scientific and regulatory understanding,” said Hilgraf. “Since I did not have much regulatory expertise yet, I decided to become a full-time student again to help fill this gap.”

Only a few weeks after taking her final class in SDSU’s fully online Master of Science in Regulatory Affairs program, Hilgraf landed a management-level job in the industry. She answered a few questions about her journey.

How did SDSU’s Master of Science in RA program meet your expectations/objectives?
My main goal for entering this program was to obtain a sound theoretical foundation of the many diverse areas within regulatory affairs. I believed that a Master of Science degree in RA would help open the door for my career transition into this field. In addition, I felt confident that a strong theoretical foundation would also be a catalyst for an accelerated career path in RA after starting my first job in RA.

This program has met, and even exceeded my expectations: I was able to find my first job in RA only a few weeks after taking my final class at SDSU. Somewhat ironically, I re-joined Vertex Pharmaceuticals at its headquarters in Boston, as my family and I had re-located there a year before my graduation. Due to my strong educational background in RA, Vertex hired me at the manager level, and I feel that this program has prepared me well for my job responsibilities.

How did you find out about SDSU’s program and what was the deciding factor in choosing it?
Before leaving my position as a scientist at Vertex, I spent about a year carefully considering and weighing my options. I reached out to people within my professional network to get connected with RA professionals, and I had many conversations. One organization that stood out for me in this process was the San Diego Regulatory Affairs Network (SDRAN) which offers a six-month mentoring program for people interested to learn more about RA.

Through that program, I connected with both an instructor and two alumni of the SDSU RA master’s program. In discussions with them, I heard about how well this program was designed, and how it was much more detailed and also demanding than other programs offered elsewhere. Initially, I had only planned to obtain the Advanced Certificate in RA from SDSU — but after only taking the first two classes, I had already changed my mind to enter the MS program, as I truly enjoyed the classes and realized their long-term benefits for my second career in RA.

What do you think are the program’s key strengths?
In my opinion, this program has two key strengths: the broad coverage of the many aspects of regulatory affairs, and excellent instructors who are working professionals in this field. With regard to the broad coverage, I feel that this program is well designed with classes covering the many different fields within RA, and also going beyond into relevant neighboring fields (e.g. clinical or ethical considerations). And the breadth of this program does not mean that it sacrifices depth; in contrast, I was positively surprised how deep and detailed we went into subject matter in each class. The second key strength of this program is the fact that RA working professionals are teaching these classes. I liked the many case studies, mock regulatory submissions, and regulatory hot topic discussions in all of my classes. In addition, instructors were always accessible by e-mail and would always respond within one day if I had any questions.

As a working professional, was the online component a critical feature?
I was one of the few non-working professionals in this program since I had decided to become a full-time student again for two reasons: I wanted to complete my MS degree in the shortest time possible, and I also wanted to have the least impact on having enough quality time with my family, especially with my young daughter. The online nature of this program was ideal for my family and me, as I was completely flexible in my time management. In addition, after my family and I relocated to Boston somewhat unexpectedly two-thirds into my program, I appreciated it even more that I could continue my studies from the East Coast without any problems or delays.

How much interaction did you have with fellow students, and are there networking aspects to the program?
Even though this program is fully online, there are many interactions with fellow students through discussion boards and team projects. I would have classes together with some students repeatedly, so we formed a sense of comradery. I even formed a friendship with one of my fellow students from my first two classes, and we recently had lunch together here in Boston even though he still lives in California. When I was starting to look for a job in Boston, I reached out to my graduate advisor, Dr. Lorah Bodie, and she connected me with a few local alumni who offered advice and help during my first job search.

What was your thesis project?
As a chemist, I am intrigued and very supportive of the FDA’s Quality by Design initiative which was started about a decade ago. With this initiative, the FDA is hoping to motivate pharmaceutical manufacturers to build quality into their products from the start throughout the whole manufacturing process, and not just trying to ensure product quality by testing at the end of the process. In my thesis, I was looking at the response of industry to a new initiative from the FDA in which the agency proposed that pharmaceutical manufacturers should submit quality metrics — an indicator of the health of a manufacturing quality system — on a regular basis. Responses from industry and other stakeholders were collected in the Federal Register, and I summarized, analyzed and discussed these responses in my thesis. Overall, responses were quite diverse and controversial, and I enjoyed closely following this real-time interaction and shaping of potentially new regulatory requirements between stakeholders and the FDA.

What did you want to be when you grew up?
I was always fascinated by science and was very determined to become a medical doctor as a child. When I had a choice between taking French or Latin in middle school, the choice was very easy for me as you needed to have had at least three years of Latin classes to enter medical school in Germany. However, in high school I got more attracted to chemistry and biochemistry and ended up studying chemistry instead. Working in a pharmaceutical company closed the loop back to my initial dream of being a medical doctor — although in a different way than I had initially thought.

Anything you’d like to add?
I started my first job in regulatory affairs nine months ago as a regulatory CMC manager at Vertex Pharmaceuticals here in Boston. Over these few months, I have had the opportunity to support one NDA filing and several clinical trial applications (CTAs) and CTA amendments for small molecule drugs. In addition, I had the privilege to be part of a team submitting one of the first CRISPR/Cas9 gene editing CTAs worldwide — a very exciting endeavor within a new, not yet clearly defined regulatory framework.

I am very happy that I took a bold step in 2014 to leave my scientific career and start a career transition into regulatory affairs. The MS program at SDSU was instrumental in helping me realize this successful transition!

Graduate Enhances ‘Dream Job’ with Master of Science in Regulatory Affairs from SDSU

By Suzana Norberg December 7, 2017

As a project manager for a medical device manufacturer, Saundra McKinley manages multiple projects to comply with requirements all over the world. “This is what allows us to access markets in over 150 countries. It’s an exciting job that genuinely helps patients with cancer gain access to treatment to save lives,” said McKinley. “This is my dream job and a perfect fit.”

Wanting to learn more about the world of regulatory affairs and the specialization her career path requires, McKinley began pursuing her Master of Science degree in regulatory affairs at SDSU’s College of Sciences. Offered in partnership with the College of Extended Studies, the program provides critical ongoing training and education to those involved with the development, testing, manufacturing, and commercial distribution of pharmaceutical, biologic, veterinary, and medical device products.

“The program was eye-opening and made a tremendous difference in my understanding the complexity and areas of specialization in regulatory affairs. I learned so much about what my co-workers and mentors know, and now I’m on par with them,” said McKinley.

She answered a few questions about her experience in the program.

How did you find out about SDSU’s Master of Science in Regulatory Affairs program?
Colleagues had attended SDSU and I asked around for recommendations. This program came highly recommended and I learned it is highly regarded! The administration was so friendly and supportive, I knew this was the way to go. I’m a remote worker, and my employer headquarters are in California. It meant a lot to me to get this degree from the California State University system.

What do you think are the program’s key strengths?
To me, the small class size and highly focused curriculum were perfect for my career intentions. I thought the instructors were typically excellent, with deep industry knowledge and experience. I thought it was amazing to learn in-depth about areas beyond regulation — such as project planning, scientific writing skills, regulatory history, and ethics.

As a working professional, was the online component a critical feature for you?
Absolutely! The program requires a lot of reading and study, and the flexibility that allowed studying as my schedule permitting was essential to me. I was surprised that this course work was very challenging and required a lot of self-discipline to understand, how to apply myself to the objectives, and how to read very carefully. In retrospect, I am delighted with having taken online courses rather than in-person courses.

How much interaction did you have with fellow students?
I met several people who I now consider a part of my network. I learned a lot from my fellow students, and I did have several opportunities for team work on projects, as well as staying in touch to check in as we went through different courses.

What was your capstone project?
My capstone project was on the new European Union Medical Device Regulation. My job is to project manage the implementation of this very large, multi-year project, and the capstone gave me the great experience of explaining the history of the regulation, how to understand the framework, and how to organize for multiple “tracks” of work to comply with the areas of our medical device business that are impacted by the regulation — post-market surveillance activities, clinical evaluation, labeling, Unique Device Identification, economic operators, and the pre-market activities such as technical file maintenance and working with our notified body. [Editor’s note: A notified body, in the European Union, is an entity accredited by a member state to assess whether a product to be placed on the market meets certain standards.] The capstone was a crucial research experience and gave me a wonderful view and opportunity to apply what I had learned in the program to what I will do in my job function for the next several years.

Can you speak to the caliber of instructors?
Some of the instructors were so expert, I am now in their fan clubs. They were terrifically accessible and genuinely interested in my success as a student, and in my career objectives. I was very impressed with the industry expertise they represented.

How did your M.S. degree in Regulatory Affairs impact your career?
My job security is much greater now and I am more respected in my field for having completed this program. The medical device portions of the program were 100 percent applicable, and it was helpful to learn about the pharmaceutical industry. Across both areas of studies, it has meant a lot to me to learn about why the regulations are in place, and how the interplay of regulation and public health drives industry.

What did you want to be when you grew up?
I never knew quite what I wanted to be! After more than a decade as a project manager, I found the perfect niche applying project management skills to regulated industry through this course of study. Now I am what I would have wanted to be when I grew up, if only I had known these things when I was younger!

Anything you’d like to add?
The administration of this program is excellent. I got a tremendous support and encouragement from the program coordinators. The coursework has a laser-focus on regulated medical industry. I recommend this to anyone who is interested in regulatory affairs. It gives both a broad perspective and a targeted focus on specific areas to help a regulatory affairs professional understand the arena, and to understand the various functions and opportunities in this career. Loved it