By Shreya Madhavarapu
The rapid development and approval of vaccines, therapies, and diagnostic tests during the COVID-19 pandemic highlighted the significant impact regulatory affairs and regulatory agencies like the FDA have on ensuring the safety and efficacy of medical products. Broadly, regulatory affairs is a profession at the intersection of industry and government. Regulatory affairs professionals are responsible for ensuring that foods, drugs, medical devices, and other products that impact public health are safe and meet set standards at every stage of development, testing, manufacturing, marketing, and distribution.
If you are interested in using your scientific background and expertise daily and ensuring that scientific innovations meet the high standards for public safety, then you have come to the right place!
On February 28, 2023, iJOBS hosted a career panel on regulatory affairs. The career panelists came from diverse backgrounds and are working at different pharmaceutical companies within regulatory affairs. The panelists were:
- Mary Lynn Mercado, Senior Group Head in Regulatory Writing at Novartis Pharmaceutical Corporation
- Abla Tannous, Regulatory Medical Writer at Bristol Myers Squibb
- Bahar Demirdirek, Director and Global Regulatory Lead of Oncology at Bristol Myers Squibb
- Helen Kang, Manager of Regulatory Affairs Strategy at Regeneron
The panelists first shared their backgrounds, decisions to leave academia, and how they landed their first jobs in regulatory affairs.
Mary Lynn Mercado received her Ph.D. in Pharmacology from Rutgers University, followed by joining Brown University as a postdoctoral researcher to develop therapeutics for muscular dystrophy. While at Brown, her advisor launched a small biotech company, prompting her to enter the industry. She started as a Senior Research Associate at Wyeth, where she conducted more applied science work. When Pfizer acquired Wyeth, Mary decided to look for jobs closer to home instead of relocating to a new location. While searching for job positions, she came across the area of regulatory writing. At her first interview with Celgene for a regulatory writer position, she utilized her scientific expertise to convince the panelists that she was ready to make a career switch despite the steep learning curve ahead of her. She has now been a successful regulatory writer for the past 14 years.
Abla Tannous completed her Ph.D. in Molecular and Cellular Biology from the University of Massachusetts, Amherst. in 2015 before joining Rutgers University as a postdoctoral researcher. During her 4 years at Rutgers, she used quantitative mass spectrometry to map the mammalian subcellular proteome and, like so many others, attended several iJOBS workshops and events. Her first job was in the pharmaceutical industry as a research scientist at BioAegis Therapeutics, where she also stumbled upon medical writing. While she had learned about it through iJOBS events, she had never considered it a profession. Working at a small company allowed her to explore these other areas of opportunity. Although hired as a research scientist, she dipped her toes in regulatory writing whenever she could. This experience led her to land her first medical writing job at BMS, where she has worked as a scientific writer since 2021.
Bahar Demirdirek completed a master’s degree in Chemistry from Rutgers and went on to work as a lab scientist in product development (small molecules) at BMS. While at BMS, she decided to pursue her Ph.D. with the support of her employers. She did this part time to continue her learning in industry simultaneously. After getting her Ph.D., she went back to BMS within the biologics drug development area. While she enjoyed bench science, Bahar wanted to learn more about the drug development process. Through this learning process, she learned about the Regulatory Strategy Team, and it interested her. Bahar was an active member of the BMS network for women and the healthcare business women association. Through this, she made meaningful connections at BMS and gained useful soft skills that helped her land a role in regulatory affairs as a junior regulatory manager. Like Mary Lynn, she had a steep learning curve but had some really great mentors who guided her along the way.
Our last panelist, Helen Kang received her Ph.D. in Immunology & Microbial Pathogenesis from Weill Cornell Graduate School of Medical Sciences in New York. Unlike the other panelists, she began her career in medical communications (also known as medical affairs) and learned how pharmaceutical companies work and function on the client side. She applied to be a Regulatory Medical Writer at Regeneron three years ago and has been with them since.
In the next phase of the event, the panelists talked about their responsibilities and what their day-to-day looks like.
Mary Lynn started her regulatory writing career at Celgene, where she was immediately thrown into the deep end. For her first clinical study report, she took a DIA course on writing a clinical study report - she received a lot of data and some example clinical reports and used all of these to write the first draft. While the report was well-received, she conveyed her need for more coaching and onboarding support. In her current role as a manager, she provides one-on-one coaching to her team members. As a manager, it is also her responsibility to strike a suitable balance between the number of writers and the workload they can handle. Mary Lynn also has the flexibility to support external organizations. She co-leads the TransCelerate Clinical Content & Reuse (CC&R) workstream, a consortium of 22 pharmaceutical companies working together to identify ways to bring quality medicines to patients more efficiently. She is also the Deputy Topic Lead for PhRMA on the ICH Clinical Electronic Structured Harmonized Protocol (CeSHarP) M11 Expert Working Group.
Although Abla is a scientific writer, she describes her work as 50% writing and 50% communication. Her typical day consists of meetings with subject matter experts like clinical scientists, statisticians, clinical trial physicians, and others. Specifically, Abla works on the submission team, where each expert writes their own section. She also oversees her team members’ writing timelines and ensures that submission deadlines are met. While this can be stressful and time-consuming, the company has recently transitioned to fully remote work, providing much flexibility.
Bahar’s primary role is developing global and US regulatory strategies for oncology products in the first three phases of development. She manages all regulatory interactions with the FDA and international health authorities. She works with researchers from different departments, including translational medicine, statisticians, medical affairs personnel, and clinicians, to understand and determine their needs and priorities while sharing the regulatory point of view. Her typical day involves meetings to coordinate work between these diverse stakeholders. Her goal, as the global lead, is to effectively communicate with regional teams and share the overall regulatory strategy. She works with members of the writing teams to review FDA submissions and other regulatory documents, such as protocols and marketing applications, which are needed to obtain regulatory approval. She enjoys working with colleagues from different backgrounds and cultures, though her role does not involve a lot of travel.
Helen’s work is currently focused on the cardiovascular space, and her typical day is similar to Bahar’s, but without the coordination between different regions across the globe. As a global lead for an early-stage study, she constantly interacts with experts across various functional areas. She also works with US and EU regional liaisons.
What are Regulatory Documents?
The panelists mentioned working on different regulatory documents. What are these documents? What is involved in an FDA submission? Mary Lynn gave us insight into this. A Clinical Trial Protocol includes information about the number of patients to enroll, inclusion and exclusion criteria, assessments to be made, endpoints, and statistical models. This is similar to a bench science protocol that includes details about the experiment (i.e., its rationale, expected outcomes, and the process of data acquisition and analysis). Once the trial is completed and data is acquired, a Clinical Study Report (CSR) is written. This is similar to an academic manuscript with an introduction, materials and methods, results, discussion, and conclusion. A CSR outlines key aspects of the trial, such as background, objectives, study design, patient selection, participant demographics, the efficacy of the intervention, endpoints, adverse events, and more. Another essential document is the Summary Document, which is compiled when a company wants to submit clinical trial results to a regulatory authority. A company may write a variety of summary documents, including efficacy, safety, clinical pharmacology, biopharmaceuticals, etc. All this information also goes into a marketing authorization application or a new drug application, which is sent to the FDA, EMA, or other health authorities around the globe. A Pharmacovigilance Document is written once a drug is on the market, and the company receives patient safety data. The company works closely with health authorities to design a clinical trial program. To correspond with them, regulatory writers use a Briefing Book. The panelists emphasized that as doctoral students, we write very relevant documents and that the writing skills we developed translate well to industry or regulatory affairs work.
Preparing for a Career in Regulatory Affairs
When considering a career in regulatory affairs, more than an advanced degree is required. This position's collaborative nature requires you to constantly communicate with different stakeholders. Hiring managers also look for candidates with the necessary soft skills to execute day-to-day tasks and with an advanced degree and preferably some prior experience in the regulatory field. The panelists recommended applying for internships or co-ops to gain valuable hands-on experience while still completing your degree. Networking is also key, so get ready and start polishing your LinkedIn skills. You should consider taking classes related to regulatory affairs, drug development and medical product regulations. You can also consider getting a certification like the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) to enhance your qualifications. Starting at a contract research organization (CRO) or even at a small company can expose you to the various facets of regulatory filing, through which you can gain the experience needed to transition into a career in regulatory affairs.
The regulatory affairs field is in high demand and is projected to continue growing in the future. This field requires a strong understanding of complex scientific, legal, and regulatory issues. For those who enjoy intellectual challenges and problem-solving, this can be a rewarding career.
This article was edited by Junior Editor Sonal Gahlawat and Senior Editor Shawn Rumrill.
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