Life science graduate students planning to transition out of academia will find a diversity of choices within industry. From attending LSCDS seminars and networking events, you can learn about these alternative career options and meet professionals from a variety of backgrounds. Recently, the LSCDS hosted guests from Regulatory and Medical Affairs to speak about their career paths at our Seminar Series. Representing Regulatory Affairs was Stephanie Croley, Ph.D., a Regulatory Affairs Project Manager at Astra Zeneca, and Yu-wen Wang, Ph.D., a Quality and Regulatory Manager with Hyland Software Canada. On the other side were Dennis Wagner, Ph.D. and Abhiram Dixit, M.D., both Medical Advisors at AstraZeneca and Sanofi, respectively. Together they provided graduate students with advice and insights on their careers in regulatory and medical affairs, respectively.

Dr. Yu-wen Wang explains the field of Regulatory Affairs.

What is Regulatory Affairs?

In the pharmaceutical sector, RAs are involved throughout the drug development process, ensuring that the company is compliant at each stage of development. Importantly, RAs coordinate between departments, such as R&D, manufacturing and marketing, to ensure regulatory guidelines are being followed. In addition to keeping track of ever-changing federal guidelines, RAs are responsible for preparing submissions to federal agencies (Health Canada and the FDA) for new drug applications and other documentation. Careers in Regulatory Affairs (RA) are not exclusive to the pharmaceutical or healthcare sectors; any regulated industry will staff RA specialists to engage with the regulatory agencies and to inform the business.

Typical duties for roles in Regulatory Affairs include:

  • Design and execute clinical trials with quality control.
  • Assess products under strict guidelines and keep proper documentation.
  • Track and maintain regulatory correspondence and submissions.
  • Use different strategies to meet changing regulations.
  • Review and observe worldwide quality control guidelines.
  • Audit tracking programs.
  • Report and document when there are problems with medical devices or products.
  • Ensure good manufacturing practice (GMP).
  • Communicate effectively with managers and regulatory agencies.
  • Technical writing and data entry.

Paths to a Career in Regulatory Affairs

Entering directly into an RA role out of graduate school can be difficult, but not impossible. New graduates should look for RA Coordinator positions, which are entry-level positions in Regulatory Affairs. But as we often learn from most professionals in industry, you can expect to take a non-linear path. For example, Stephanie Croley’s journey to becoming a Regulatory Project Manager had many stops along the way. During her undergraduate degree, Stephanie found a clinical internship at GlaxoSmithKline, which helped her build industry connections. She later decided to pursue a Master’s degree in Biotechnology from the University of Toronto. Since an internship was part of her program requirements, she tapped into her connections at GSK and found another role on their medical team. Following a short stint in clinical trials, she found her way back at GSK as a Regulatory Associate. Thus, building your network and gaining industry experience in other roles is a great way to maneuver into Regulatory Affairs.

There are other paths into Regulatory Affairs that Yu-wen Wang says could help but are not required for landing a job. While she found her position as a Quality and Regulatory Manager through attending a seminar and networking, she also pointed out the option of completing a Regulatory Affairs Graduate Certificate program. These programs offer in-class instruction and internships that help you gain that first bit of experience within industry. Some programs available in the GTA include:

  1. [email protected]: Pharmaceutical Regulatory Affairs and Quality Operations
  2. Humber College: Regulatory Affairs
  3. Northeastern University: Master of Regulatory Affairs for Drugs, Biologics and Medical Devices

Yu-wen also offered this tip for interviewing for RA positions: learn the lingo! This means learning the language RA specialists speak and the terms they use to stand out in your interview. Check the following links for guidelines and resources to help you prepare for an interview.

  1. Regulatory Affairs Professionals Society | RAPS
  2. The Organisation for Professionals in Regulatory Affairs (TOPRA)
  3. Elsmar

What is Medical Affairs?

Dr. Abhiram Dixit discusses the pros and cons of working as a Medical Science Liaison.

Medical Affairs encompasses a wide variety of jobs within the pharmaceutical and healthcare sectors, but at the end of the day, the essence of the field is to maintain strong relationships between healthcare providers (HCPs) and pharmaceutical companies. This requires clear, bidirectional communication of medical insights and pharmaceutical knowledge between the two parties. As such, Medical Affairs is a strategic driver for Pharma. Medical Science Liaisons (MSLs) make up the front line of Medical Affairs, going into the field to advocate for HCPs and Pharma alike by presenting novel therapeutic products to the former and bringing back medical insights to the latter. MSLs are thus heavily involved in the product launch phase of many pharmaceutical companies. Additional key perks of working as an MSL include being the first to know about new therapeutics, meeting new people, and frequent traveling. MSLs can move up the career ladder by becoming Medical Advisors, a role that includes developing the company’s Medical Affairs Strategy, organizing outreach and educational programs, and managing MSLs.

Paths to a Career in Medical Affairs

For Dennis Wagner, delving into Medical Affairs was the result of “a series of random events that eventually collided [into something big].” Having developed a keen interest in the interface between science and business early in his PhD years, Wagner built his soft skills outside academia by volunteering for mini-projects and leading student organizations like the LSCDS. This put him on the radar, and he started landing consulting positions by the end of graduate school. From then, the path was clear: “once you’re in industry, you’re hot commodity,” he explains, adding that competitors constantly try to hire you out. As such, Wagner jumped from Medical Science Liaison at GSK, to Medical Scientist with Gilead Sciences, to his current role as Medical Advisor for AstraZeneca within the past decade. The key to his success? Wagner advises students to move from “talking to walking”: find opportunities to showcase your skills to industry contacts, use these to differentiate yourself from the candidate pool, and don’t underestimate other jobs as stepping stones towards your dream career.

Dr. Dennis Wagner walks us through his journey from PhD student to Medical Advisor at AstraZeneca.

As a practicing physician in India, Abhiram Dixit’s path into Medical Affairs may seem, at surface level, quite different than those of the seminar’s attendees. Nevertheless, his key insights and tips remain just as applicable. After spending several years staring down the microscope as a pathologist, Dixit decided it was time for a change. He moved to Canada and, seeking something with more person interaction, landed the role of MSL. Sharing with us a glimpse of his daily schedule while he was an MSL, Dixit comments on the large amount of waiting and commuting he has to do. Indeed, being on the field means visiting physicians at hospitals and bringing their insights back to the office – waiting and commuting are thus a natural part of the job, as are disappointed and sometimes unfriendly HCPs. Yet the pros outweigh the cons: MSLs frequently travel to meet new clients and help shape the company’s product research and launch processes. Today, Dixit is a Medical Advisor at Sanofi, where he occasionally oversees the hiring of new MSLs. What does he look for in a candidate? Most pharmaceutical companies use a computer algorithm to screen resumes, so the ones Dixit views have passed the initial test. These resumes need to reflect good business understanding and, importantly, be aware of the lingo in industry. Then comes the interview. “Presentation and communication skills are part of it,” Dixit says, “Really putting everything to the interview is the key to it.”

Final insights and tips on pursuing Regulatory or Medical Affairs

Whichever career path you choose, one important tip for successfully transitioning from graduate school to that dream job is to network appropriately! Networking events may provide you with the doors to Pharma, but building meaningful relationships and finding opportunities to showcase your skills to industry contacts are keys to getting your foot at the door. Finally, remember that it only takes one interview to land a job, so be sure to ace it!

Next Up

The LSCDS is hosting the next Seminar series on November 27th on Career Development Opportunities with Mitacs.


References:

https://settlement.org/alternative-jobs/pharmacist/pharmaceutical-regulatory-affairs-and-quality-operations-associate/