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.
Current Job Openings
Clinical Research Associate (CRA)
This position performs and coordinates all aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products...(more)
Clinical Research Coordinator (CRC)
Job Summary-
The Research Nurse Coordinator manages clinical research projects for Principal Investigator via study protocol within the University, competently performs the nursing...(more)
Clinical Data Manager
As part of a clinical working group, the Sr. Clinical Data Manager (CDM) is responsible for the accuracy and completeness of the clinical data collected during a clinical...(more)
Clinical Data Manager
:
Under general supervision, the Clinical Data Manager reviews data; assists in database design and testing; designs CRFs and guidelines; designs and tests logic checks;...(more)
Clinical Research Coordinator (CRC)
Fast growing physicins group seeking seasoned CRC for location 90 miles northeast of Raleigh, NC. Group conducts research across wide variety of therapeutic arenas.
Job Responsibilities...(more)
Clinical Research Associate (CRA)
:
CLINICAL RESEARCH ASSOCIATE II
This is a lead position. The Clinical Research Associate II manages the implementation of study protocols at research sites. Responsibilities...(more)
Clinical Project Manager
Title: Clinical Trials Project Manager
General Summary:
The Clinical Trials Project Manager will report to and work closely with the Project Director in the coordination and management of...(more)
Clinical Research Associate (CRA)
Title: Clinical Research Associate
Country United States
Description
- Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (40 - 50% travel) for GCP...(more)
Clinical Research Associate (CRA)
This position performs and coordinates all aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products...(more)
Biostatistician
Job Summary
Act as the lead or back-up statistician for Kendle projects with low to moderate complexity. May act as the supportive statistician for Kendle projects with...(more)