A Pharmacy Regulatory Affairs Manager is the person responsible for running and monitoring the pharmacy department in a hospital, clinic, or community wellness center. They are in charge of ensuring that all personnel are compliant with all the current, up-to-date pharmacy/pharmaceutical laws and regulations. They are responsible for making sure that the pharmacy’s projects and proposals “meet all relevant guidelines, standards, and regulatory rules, conducting research where needed. [They] Oversee preparation, data, testing procedures, and compliance aspects of proposals and reports. [They also] Investigate and report adverse events, compliance violations and similar problems.” This is an administrative position within a pharmacy context, so while pharmaceutical and medical knowledge is required, it is not generally part of the day-to-day job
The requirements vary, but generally one must possess at least an M-Pharm from an accredited, PCI-approved university, and have several years of experience in a managerial position in a pharmacy, hospital, or a pharmaceutical company. An MBA or a business background is a plus, since it’s a position that requires managing other people, various projects, and sometimes departments.