INTERNSHIP DETAILS

Co-op, Regulatory Affairs - Summer 2026

CompanyEnable Injections Inc.
LocationSharonville
Work ModeOn Site
PostedMarch 11, 2026
Internship Information
Core Responsibilities
The role involves assisting with literature research, responding to customer inquiries, and aiding in the preparation of regulatory submissions like master files and technical files. Responsibilities also include supporting country-specific labeling requirements and tracking various regulatory documentation such as licenses and registrations.
Internship Type
full time
Company Size
207
Visa Sponsorship
No
Language
English
Working Hours
40 hours
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About The Company
Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience. Enable's body-worn enFuse® delivers large-volume therapeutics via subcutaneous administration, with the aim of improving convenience, potentially supporting improved safety outcomes, and advancing healthcare system economics. For more information, please visit www.enableinjections.com. *The enFuse System has received device marketing authorizations from several ex-U.S. regulatory authorities. Combination product approval with a specific drug granted in the U.S. More information: enableinjections.com/approvals
About the Role

Location: Onsite

Status Type: Full Time

 

QUALIFICATIONS

 

Required:

  • Pursuing a bachelor’s degree in science, engineering, or a related field

 

Skills & Competencies:

  • Ability to participate as a team member
  • Ability to work independently
  • Good interpersonal and organizational skills
  • Good written and verbal communication skills
  • Strong understanding of Quality Systems Regulations
  • Good time management skills
  • Ability to follow defined procedures
  • Ability to collaborate and maintain cooperative work relationships with others
  • Ability to adapt to change and handle unexpected situations with close guidance
  • Ability to stay focused on tasks, organize, compare, interpret basic data, and assess problems with guidance

 

Physical Requirements:

  • Must be able to remain in a stationary position for extended periods of time
  • Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. 
  • Ability to move about inside the office to access file cabinets, office machinery, etc.
  • Position requires being physically present on the premises during regular company hours or as approved by management

 

RESPONSIBILITIES:

  • Assist with literature-based research and assist with responses to customer requests for information
  • Assist in the preparation of master files, technical files, or other regulatory submissions
  • Assist in the preparation of documentation needed to support investigational clinical studies
  • Assist with country-specific labeling requirements
  • Assist in tracking labeling, change controls, licenses, and registrations
  • Identify areas for improvement, problem-solve, and suggest solutions
  • Complete simple or basic tasks to include any of the following: writing and/or verifying specifications, maintaining product/process documentation

 

Key Skills
Team MemberWork IndependentlyInterpersonal SkillsOrganizational SkillsWritten CommunicationVerbal CommunicationQuality Systems RegulationsTime ManagementFollow ProceduresCollaborationAdaptabilityProblem-SolvingData InterpretationLiterature ResearchRegulatory Submissions
Categories
Science & ResearchLegalAdministrative