Position

Intern-Regulatory Affairs (Tarrytown, NY)


Department:

Regulatory Affairs

Our summer Regulatory Affairs Intern position supports Regulatory Affairs in a variety of short-term projects and tasks. This in-person position works approximately 3 days/ 24 hours per week.  The candidate will work closely with and report to the Regulatory Affairs leadership team to gain experience in the RA life cycle process.  

In this role, the Intern will have exposure to the broad scope of global Regulatory Affairs.  While providing valuable support to a dynamic group, the Intern gains insight into regulatory pathways; how drugs, medical devices, dietary supplements, and cosmetics are brought to market, and promoted within the legal frameworks governed by the Food & Drug Administration (FDA) and the Federal Trade Commission (FTC).

Primary responsibilities:

  • Perform research and analysis, through internal and external resources, as needed to support regulatory initiatives.
  • Prepare forms for review and submission to EPA, FDA, Health Canada, or foreign regulatory authorities.
  • Conduct a preliminary review of product applications and labeling for errors in spelling, grammar, or general formatting.
  • Provide administrative support; perform product and manufacturing site registrations including drug/device listings, for the US and Canada markets, data entry into the WERCSmart/ Smarter Sorting portal
  • Aid departmental efforts to organize, update and maintain electronic regulatory files.

Qualifications: 

  • High level of organizational and planning skills
  • Analytical, problem-solving skillset
  • Detail-oriented, highly motivated, able to manage multiple tasks
  • Ability to work well in teams in an effective and positive manner
  • Possess a can-do approach and courage to speak your voice and suggest innovative ideas
  • Strong oral and written communication skills  
  • Prior work in an office setting is highly preferred
  • Proficiency with Microsoft applications (Excel, Word, PowerPoint, Outlook) and Adobe PDF software
  • Student currently enrolled in an undergraduate program, pursuing a degree majoring in scientific, pharmacy, or engineering-related fields or similar areas of focus

Prestige is an Equal Opportunity Employer

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