How to become a regulatory affairs pharmacist

The pharmaceutical industry is highly regulated, and for a good reason. Laws and regulations are set to ensure that consumers and patients can access safe and effective medications, medical devices, and other products. In order to test, market, and release drugs onto the market, pharmaceutical companies must abide by government regulations and oversight processes. 

Regulatory affairs, however, encompasses more than just the pharmaceutical industry. Supplements, pesticides, foods, and cosmetic products are also heavily regulated. Due to the variety of industries that need assistance with regulatory affairs, many people who work in regulatory affairs come with advanced degrees from different backgrounds, such as public health policy, biomedical engineering, and nutritional sciences. 

Why is regulatory pharmacy important?

Regulatory affairs pharmacists can be essential parts of the drug approval process, in particular. Pharmaceutical companies need regulatory affairs pharmacists to assist with handling scientific and legal requirements, coordinating with regulatory agencies, and obtaining market authorization, among other responsibilities. Without help from a regulatory affairs specialist, pharmaceutical companies could face delays in obtaining drug approval. Continue reading to learn more about how to become a regulatory affairs pharmacist. 

What is a regulatory affairs pharmacist?

Regulatory affairs pharmacists are involved with the regulatory processes for developing and marketing a drug. These types of pharmacies act as the contact between the pharmaceutical company and regulatory agencies, such as the FDA. They are involved with assessing the safety, quality, and efficacy of drugs during the initial clinical trials, marketing stage, and post-marketing surveillance stage. 

Regulatory affairs pharmacists can work in the public or private sector. Pharmacists who work in the public sector often work for a government body to create policies and guidelines that help protect patients. Pharmacists who work in the private sector typically work for a pharmaceutical company.

What does a regulatory affairs pharmacist do?

The duties and responsibilities of a regulatory affairs pharmacist may include:

• Securing authorization for the use of a medication in a clinical trial
• Assessing and communicating the regulatory guidelines for medication approval
• Collecting, evaluating, and managing data from clinical trials 
• Compiling the documents needed to obtain authorization for a new drug or designate a new indication or formulation for a previously approved drug
• Applying for permits and submitting required paperwork to regulatory agencies
• Reviewing marketing material to ensure compliance with regulatory policies
• Relaying information to and from regulatory officials and responding in a timely manner
• Advising regulatory teams and departments on updates in laws and regulations
• Presenting documents to the appropriate regulatory agency and making changes as necessary 

Regulatory affairs pharmacists may have a variety of different responsibilities depending on the company they work for. They are critical for the success of drug approval processes and compliance with local, state, and federal legislation. 

Regulatory affairs pharmacist salary

The salary for regulatory affairs pharmacists can vary based on several different factors. These factors include location, company, education, job experience, and credentials. Entry-level jobs will typically pay less than jobs that require years of experience with advanced credentials. 

On average, according to salary.com, a regulatory affairs pharmacist’s salary is around $120,000 per year. On the low end, regulatory affairs pharmacists make around $100,000. On the high end, they make about $146,000. 

There is usually room to grow in the regulatory affairs field. You can expect to make more as you advance into leadership positions. However, the starting salary of a regulatory affairs pharmacist may be skewed toward the lower end of the typical salary range for pharmacists. 

How to become a regulatory affairs pharmacist

A regulatory affairs pharmacist career path starts with becoming a pharmacist. Regulatory affairs pharmacists will have graduated from an accredited pharmacy school program (Pharm.D.) and be licensed as a pharmacist through the Board of Pharmacy. Some regulatory affairs pharmacists may have a Bachelor of Pharmacy degree (B.Pharm.) or a Master of Science in Regulatory Affairs. 

Entry-level positions often provide training on the job, while advanced positions may require years of experience. Demonstrating a competent level of knowledge of operations and guidelines in the industry is generally required by most companies. Professionals who are already working in regulatory affairs can obtain the Regulatory Affairs Certification (RAC) to showcase their knowledge and commitment in the field. Having the RAC is not usually a requirement by companies, but it may be preferred.

The skills needed to be a successful regulatory affairs pharmacist include attention to detail, analytical skills, organizational skills, and negotiation skills. In addition, regulatory affairs pharmacists will need to be able to work in team-based environments. Being a good communicator is also essential for working in regulatory affairs. 

Pros and cons of regulatory affairs pharmacist jobs

Working as a regulatory affairs pharmacist can come with various pros and cons. The APhA Career Pathway Evaluation Program survey asked pharmacists working in pharmacy law, regulatory affairs, and public policy what they found most and least appealing about their job. The survey included participants working in any of these three fields.

Over half of pharmacists (63%) reported that they were extremely satisfied with their job. A quarter of the pharmacists who reported they were satisfied with their job attributed their satisfaction to different factors. A career in regulatory affairs can be challenging and provides opportunities for growth through the various responsibilities and duties it entails. A quarter of respondents said they felt they had an impact on public and patient safety. The schedule of a regulatory affairs pharmacist can also be flexible and involve traveling both domestically and internationally. 

Some pharmacists report that office politics and administration are not enjoyable aspects of the job. In addition, 16% of pharmacists revealed that travel was not appealing. As such, pharmacists may have different perspectives on the pros and cons of jobs in regulatory affairs. Someone who has a family or other ties to a specific place may not enjoy being away from home as much as someone who is single with no kids. 

How to stand out as a regulatory affairs pharmacist 

Getting a job in regulatory affairs is not always straightforward, and the path isn’t always laid out in pharmacy school. It can be competitive to get a foot in the door without the right experience. Fortunately, there are some ways to improve your resume.

Get experience early

If you have a slight interest in regulatory affairs as a pharmacy student, you can kickstart your career by completing experiential program requirements at a pharmaceutical company. Work with your school’s curriculum adviser to find rotations in regulatory affairs. You might also decide to work as an intern at a pharmaceutical company throughout pharmacy school. As an intern, you’ll be able to get exposure to different aspects of regulatory affairs. Then, after you graduate, you could have the chance to work for them as a pharmacist. A company may be more likely to interview and hire someone internally, especially someone who they’ve already trained and become acquainted with. 

Reach out to consulting firms 

Regulatory affairs consulting firms are companies that assist pharmaceutical companies with regulatory processes. They often assign an expert or group of experts to handle the regulatory processes for clients. You can reach out or apply to entry-level jobs at these firms to get some experience. Many of these firms may offer on-the-job training for regulatory affairs pharmacists. 

Seek extra training or certifications

Different organizations and universities offer courses and programs to train and educate professionals interested in regulatory affairs. These courses and programs can vary in the material they educate you on, ranging from introductory level to advanced. However, it’s best to vet each program with the outcome you expect to achieve and ask other professionals in the field about their recommendations. 

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Network and find a mentor

As with finding a job in any field in pharmacy, networking can go a long way. You can join a specific organization, such as the Regulatory Affairs Professionals Society (RAPS) or Industry Pharmacists Organization (IPhO), to connect with pharmacists who are already working in the field. You can also connect with regulatory affairs pharmacists on LinkedIn and find out more about what it’s like working in the industry. 

Working in regulatory affairs can be an ideal career for many pharmacists. Breaking into the field may be more competitive than other niches of pharmacy. However, networking and building your resume with experience are a couple of the best ways to go about becoming a regulatory affairs pharmacist.