Spotlight Employers
Regulatory Affairs Specialists
The Regulatory Affairs Specialist holds the responsibility of ensuring that all necessary forms and applications are completed and filed on time with the appropriate government agencies. This role also handles all government relations in regard to all clinical activities requiring government approval. The Regulatory Affairs Specialist assists other members of the clinical team to develop processes and procedures to ensure regulatory compliance.
Qualified candidates must possess a four-year or advanced degree in addition to clinical environment experience and familiarity with regulatory compliance guidelines. At the entry level, individuals report to a senior-level Regulatory Affairs Specialist; however, this line of work carries a great degree of detail, responsibility and autonomy.
Employment Outlook
Opportunities for Regulatory Affairs Specialists can be found in hospitals, contract research organizations, biomedical research organizations and institutions, sectors of the government, and specialty disease centers and pharmaceutical and medical device suppliers. Regulatory Affairs Specialist positions are expected to increase 10% or more in the next 10 years. Regulatory Affairs Specialists earn an average of $28.02 to $36.78 an hour for an annual salary of $58,300 to $76,500 a year or higher, depending on degrees obtained, the research setting, credentials and experience.
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