Regulatory Affairs

Regulatory Affairs Specialists

A regulatory affairs specialist, at the entry level, coordinates and prepares document packages for submission to regulatory agencies, internal audits, and inspections. He or she compiles all material required for submissions, license renewals, and annual registrations. An incumbent monitors and improves tracking and control systems and keeps abreast of regulatory procedures and changes. He or she may work with regulatory agencies and recommend strategies for earliest possible approvals of clinical trial applications. An entry-level position requires a bachelor of science degree or equivalent and a minimum of 0 to 2 years' related experience.

Documentation Coordinator

A documentation coordinator provides clerical and administrative support related to a company's documentation system requirements. He or she audits all documentation manuals to ensure that they are accurate and up-to-date and available to appropriate personnel. A documentation coordinator also files and retrieves all master documents. The position requires a high school diploma or equivalent and a minimum of 0 to 2 years' related experience.

Documentation Specialist

An entry-level documentation specialist is responsible for coordinating all activities related to providing required documentation and implementing related documentation systems. He or she coordinates the review and revision of procedures, specifications, and forms. He or she also assists in compiling regulatory filing documents and in maintaining computerized files to support all documentation systems. The job requires a bachelor of science degree in a related field or equivalent and a minimum of 0 to 2 years' experience in documentation, quality assurance, technical writing or the equivalent.