Regulatory Affairs Co-op

This Regulatory Affairs Co-op position at Enable Injections involves assisting with literature-based research and responses to customer requests for information. The role also assists in preparing master files, technical files, and other regulatory submissions for clinical studies.

Daily responsibilities include assisting with country-specific labeling requirements and tracking labeling, change controls, licenses, and registrations. The co-op will also help prepare documentation for investigational clinical studies and identify areas for improvement, problem-solve, and suggest solutions.

This position requires the ability to participate as a team member while also working independently. Candidates must have good interpersonal and organizational skills, as well as a strong understanding of Quality Systems Regulations. The role involves following defined procedures and maintaining cooperative work relationships.

This co-op offers exposure to the regulatory affairs field within the pharmaceutical industry. Participants will assist with writing and verifying specifications and maintaining product and process documentation. The experience helps develop skills in problem-solving and adapting to change.