Regulatory Pharmacist: Education and Career Information
The pharmaceutical industry is among one of the most regulated fields out there. Specialized pharmaceutical professionals or regulatory pharmacists help ensure that pharmaceutical regulations are met. These professionals interface with government regulatory agencies and pharmaceutical businesses to facilitate the transition from a drug’s conception to the final approval.
What does a Regulatory Pharmacist do?
Regulatory pharmacists help ensure that drugs and medical products meet certain regulations before they are put on the market. They handle all of the red tape that goes into a successful release of a drug. They coordinate with pharmaceutical companies and scientists to facilitate drug research, plan drug trials and review and interpret scientific report data. They also apply for approvals and permits from the Food and Drug Administration. They might also coordinate with international regulatory offices as well. Some of the job duties of regulatory pharmacists might include:
•Being responsible for ensuring compliance with applicable government rules and regulation
•Determine and communicate drug approval requirements
•Compile and submit documents to regulatory agencies
•Participate as a member of a regulatory team
•May review drug promotional and advertising material to ensure that it is compliant with regulations
•Respond to regulatory officials and meet deadlines
The work that pharmaceutical regulatory professionals do is vital and has a range of implications. They make sure that drugs meet certain federal and state guidelines. Regulatory professionals help ensure that the public has access to safe and effective drugs.
How much does a Regulatory Pharmacist Earn?
The salary of a regulatory pharmacist varies depending upon several different factors, which include:
•Level of education
•Years of pharmaceutical and regulatory experience
•Region in which they work
According to the Regulatory Affairs Professional Society’s 2014 Scope of Practice and Compensation survey, the outlook for pharmaceutical regulatory professionals is good. The average salary for jobs in this field is just over $126,000 in the United States.
What Types of Skills are needed to become a Regulatory Pharmacist?
The work that regulatory pharmacists do involve a lot of details. Regulatory pharmacists must keep up with evolving government regulations. There is typically a lot of technical writing. Regulatory pharmacists often have to review documents, some of which might be thousands of pages long. Here are some of the most critical skills for regulatory pharmacists:
•Detail oriented – Because just one small oversight could have deleterious implications for safety or it could delay the release of a life-saving drug
•Advanced knowledge of science and research methods
•Excellent organizational skills
•Ability to work independently or part of a team
•Leadership skills – For more advanced positions
•Excellent grasp of English language – Must be able to read and understand scientific documents.
•Ability to handle stress – To meet tight deadlines and work well in a fast-paced environment. Must manage multiple projects and deadlines.
•Excellent communication skills – To communicate with government officials
Internship Requirements to become a Regulatory Pharmacist
Internship requirements vary based on the degree program and school. Entry level regulatory pharmaceutical jobs may require on-the-job training while higher level positions might require an internship.
Educational Requirements to become a Regulatory Pharmacist
For most entry-level pharmaceutical regulatory positions, a bachelor’s degree is the minimum requirement. The Regulatory Affairs Professional Society reports that nearly all regulatory professionals — 99 percent — have college degrees. Most employers look for a major in the sciences or a related field. Ninety-four percent of regulatory pharmacists hold degrees in the sciences.
For higher level positions, a Master’s Degree or Ph.D. may be required. In fact, sixty-nine percent of regulatory professionals have master’s degrees or higher. Some pharmaceutical regulatory jobs require that the person is a pharmacist. Pharmacists must have a Doctor of Pharmacy Degree or Pharm D. degree. These programs require courses in pharmacology, chemistry, and medicine. Pharm.D. students also complete internships and other supervised work experiences.
Here are some examples of appropriate degree programs for a career in regulatory pharmacy and the typical coursework for each degree.
Bachelor of Science
There are a variety of bachelor degrees that would work for entry-level careers in regulatory pharmacy. Some examples include a bachelor’s degree in chemistry or biological science. Students in these programs typically take coursework in pharmacology, biology, mathematics, chemistry and toxicology.
These programs are ideal for students that already have a bachelor’s degree in science and want a higher-level position in regulatory pharmacy. A master’s degree in regulatory science usually includes courses in chemistry, clinical research, pharmacy administration and pharmaceuticals. Most master’s degree programs require an internship.
A PharmD degree is needed to be a pharmacist. It usually includes coursework in pharmaceuticals, biological systems, cell biology, mathematics, pharmacy administration, and therapeutics. A PharmD program typically involves professional clinical practice and internship courses. Sometimes, PharmD programs are combined with a master’s degree in regulatory science. The combination of master’s degree in regulatory science and PharmD is perfect for a career as a regulatory pharmacist.
Choosing a Program in Regulatory Pharmacy
When it comes to selecting a program in regulatory pharmacy, there are a couple of things to keep in consideration.
Is the Program Accredited?
Make sure that the program that you are considering is approved by the appropriate licensing or certification body or agency. Check to make sure that the program is also accredited by professional organizations. The reason that accreditation is so important is that it ensures that the program has met certain standards. It also helps you meet requirements for professional licensing in your state.
What is the graduation rate in the program that you are considering? This is an important question because it can help give you an idea of how much support you will get from the programs. If you notice a meager graduation rate, it could mean that students are not getting the help that they need to meet graduation requirements.
Some other things that you might want to consider when choosing a program include tuition and fees and student aid. Graduate school, in particular, can be expensive. It is important to look at the tuition and also determine what kind of financial aid or assistance is available to students.