Regulatory Affairs Q&A (Part 1)
Source: Photo taken at the FDA during my pharmacy school externships.
What is regulatory affairs?
‘Regulatory affairs’ is a profession within regulated industries such as, but not limited to, pharmaceuticals, cosmetics, medical devices. The profession emerged from governments’ desires to protect the public by regulating these industries. There are many career options in regulatory affairs, but I will specifically focus on regulatory affairs as it pertains to drug development within the pharmaceutical industry.
How would you describe what it is like to work in regulatory affairs?
The work in regulatory affairs is project based and the activities are that of a typical office job. There are aspects to the job that are exciting and mentally stimulating, but there are also parts to the job that are less enjoyable but required (ex. operational and/or administrative work).
Projects vary and the daily activities are never exactly the same. Responsibilities depend on your role at a company and the size of said company. For example, in my current role I develop and share regulatory and drug development strategies to help move company programs forward and ultimately towards a drug approval by the FDA. I routinely collaborate with internal customers (i.e. my work colleagues) and external ‘customers’ (i.e. government agencies or business partners), and I regularly complete regulatory submissions domestically and abroad.
If you enjoy working as an individual and team contributor on projects that may better medicine and positively impact patients on a global scale, then you may enjoy working in regulatory affairs.
Do you travel for work?
Regulatory affairs is headquarters based. However, remote opportunities have become more prevalent thanks to COVID. Depending on your role and your company’s needs, you may end up traveling for conferences, engagements with internal/external business partners, and more. Traveling for work is not common at the entry level, but individuals at the executive level may may be required to travel more frequently.
If you are given an opportunity to travel for work, then take it. I was fortunate to receive projects that helped me grow as a regulatory affairs professional and to travel outside of and within the United States. My fondest memory of traveling for work was when I had to fly to the European Medicines Agency (EMA) headquarters, which at the time was located in Canary Wharf, United Kingdom. I will never forget the moment when the reviewers from the Committee for Medicinal Products for Human Use (CHMP) notified the team that the CHMP would recommend our medicine be approved to treat breast cancer patients. A lot of champagne was consumed that day.
What do you think the qualities of a ‘good’ regulatory affairs professional are?
A scientific and patient centric thought process, attention to detail while not losing sight of the broader vision, a strong understanding of drug development, proficient written and verbal communication, leadership ability, commercial and business savvy, courage, and creativity.
What kind of training or education do I need to get into regulatory affairs?
I would recommend at least a graduate degree. The competitive landscape has made it harder to get into regulatory affairs without a graduate degree. It is possible to enter regulatory affairs with only a bachelor’s degree, but it is more challenging. Internships and/or experiences in regulatory affairs and/or relevant industry experiences are also helpful for getting into regulatory affairs.
I believe the training, knowledge, and the proper externships obtained in pharmacy school lay the foundation for a career in regulatory affairs, so I think Pharmacists should consider the opportunities available in regulatory affairs.
How much do regulatory affairs professionals make?
Salaries vary by company size, company location, experience, education, and more. I have provided salary estimates below. These estimates are for regulatory strategists working in ‘clinical’ regulatory affairs and were obtained through research online, my discussions with individuals in the field, and discussions with recruiters (edited timestamp: July 2022).
Coordinator: $40,000 - $70,000
Associate/Senior Associate: $65,000 - $100,000
Manager/Senior Manager: $90,000 - $150,000
Manager/Senior Manager/Associate Director: $130,000 - $200,000
Director/Senior Director/Executive Director: $180,000 - $260,000+
Vice President/Senior Vice President/Chief Regulatory Officer: $260,000-3XX,000+
Salary ranges are wide and may overlap with other levels. Salaries can start at the lower end of a pay band to allow an individual to grow in a role they may have not yet served in. Again, these salary ranges are just estimates. Of note, salary is just one aspect of a compensation package.
Author’s Note
I hope you found these insights helpful. If you are interested in learning more, then stay tuned for part 2 and send me a note with any question you would like answered.
