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This article is a part of a series of The Many Paths of Pharmacy, which has 48 other pharmacy career paths.

Summary – Pharmacists in Regulatory Affairs

Regulatory affairs were created to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, and complementary medicines. This mandate created a professional niche for pharmaceutical companies.

Regulatory affairs pharmacists are concerned with the regulations and guidelines for clinical trials and other aspects of medical research.  Most countries require government approval for a product, thus, all trials must follow strict guidelines to reach the marketplace.  A career in regulatory affairs is in either the public sector (government body or public policy) or in a pharmaceutical company.  A pharmacist in public policy works to create and enforce regulations, guidelines, and laws for patient protection.

Here is an interview with Shama Patel on how she transitioned from retail to Medical Affairs, a field very close to Regulatory Affairs, but is more focused on the product after approval.

Responsibilities of a Regulatory Affairs Pharmacist

Regulatory Affairs Pharmacists work in a team-based environment with scientific leaders, research teams, marketing, and executive teams to successfully bring a product to market. These pharmacists are responsible for the following:

1. Tracking the ever-changing legislation in necessary target market regions
2. Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information for the regulatory department
3. Advising on legal and scientific restraints and requirements
4. Collecting, collating, and evaluating scientific data
5. Presenting registration documents to regulatory agencies and carrying out any subsequent clarifications or negotiations necessary to obtain or maintain marketing authorization
6. Providing strategic and technical insight at the executive level
7. The regulatory affairs department will often take part in the development of product marketing concepts and is commonly required to approve packaging and advertising before it is used commercially

This Pharmacy Regulatory Affairs Career Description is a part of The Ultimate Guide to Pharmacy Careers, part of our future book, POTENTIAL.

Requirements of a Regulatory Affairs Pharmacist

Pharmacists complete four years of graduate coursework resulting in a Doctor of Pharmacy degree (PharmD), with the greatest concentration in pharmaceutical education as compared with doctors and all other health care professionals. Entry-level regulatory pharmaceutical jobs may require on-the-job training while higher-level positions likely require years of experience, or experience in a related field such as quality assurance, research and development/support, scientific affairs, or operations.

Pharmacists in this field can earn the professional credential of Regulatory Affairs Certification (RAC), however, this is usually a preference and not a requirement.

Attention to detail is critical because just one small oversight could have deleterious implications for safety or delays the release of a product. Knowledge of the regulatory cycle is essential, as this is a highly regulated process and time is of the essence. Strong interpersonal skills are often listed as a job requirement on job postings due to the highly team-bound nature of regulatory affairs. The ability to organize one’s time and priorities is of utmost importance given the timed nature of the work, as you will be likely measured by your ability to complete deadlines.

Salary of a Regulatory Affairs Pharmacist

According to Zipruiter.com, the average annual pay for a Regulatory Pharmacist in the United States is $99,793 per year. This may surprise many, as one could expect the pay significantly higher given a pharmacist’s training. However, regulatory affairs positions are sought after by multiple (lower average pay) professions, thus diluted the salary offer. The range typically falls between $67,500 and $122,500.  Salary ranges can vary widely depending on many important factors, including education, certifications, additional skills, and years of experience.

Pros and Cons of Being a Regulatory Affairs Pharmacist

A major benefit is an impact on public and patient safety, the ability to make decisions that affect clinical research, patient care, and public safety related to products. If you love the idea of keeping patients safe from a large-impact scale, then this job will be highly satisfying. Regulatory Affairs positions are crafted for flexible work hours, new and daily challenges, sweeping changes in the field. You will never be bored with the next challenge. For some, this pro could be a con, but frequent travel (sometimes international) and exposure to multiple cultures will be an experience to add.

A common negative aspect of entry-level regulatory affairs pharmacist positions is the contract nature of the job. Many companies only focus a finite amount of time on regulatory affairs approval. Thus, it is easier to compete for a contract job as an entry point into the profession, however, do not expect to be brought on full-time once product approval is granted. Some other cons are administration bureaucracy and excessive time away from home.

How to Stand Out as a Job Candidate in Regulatory Affairs

Your strongest ally in this market will be your network. Never underestimate who knows who in this niche. A simple introduction and conversation could be all that separates you from an entry-level job. And that’s the important point to focus on: entry-level. You must be willing to start at the bottom to secure a place at the top. Few pharmacists wish to take the risks of an entry-level position, but the beauty of starting a career path here is that it’ll lead to the next opportunity. Once immersed in the regulatory niche, you’ll find new opportunities. But you can’t be lazy on this path. Once hired, you’ll need to keep “one ear to the ground” about new drug developments, company news, press releases, and the like to keep abreast with the latest information about where the next job will come from. Building experience in the private sector can lead to a more stable position in a larger company or potentially work for a government body.

Displaying your communication skills will also benefit you. The most successful Regulatory Affairs pharmacists are those who have great communication and writing skills, willingness to continue to learn throughout their career, and understand there are no right or wrong answers. Share your knowledge online by writing articles, presenting data, or sharing information, as this can attract your next employer.

Prepared by Kingsley Aguebor, PharmD Candidate

Interviewed: Dr. April Nguyen

Edited: Alex Barker, PharmD