Regulatory Affairs Intern

Harrow, Inc.

15h • Hybrid

About The Position

The Regulatory Affairs Intern will support the Regulatory Affairs team with day-to-day activities across product lifecycle management, regulatory submissions, and compliance. This role provides hands-on exposure to FDA regulatory processes, including IND and NDA submissions, CMC documentation, labeling review, and agency correspondence. The intern will collaborate with cross-functional teams, including R&D, Clinical, Quality Assurance, Manufacturing, and Medical Affairs, to gain a well-rounded understanding of regulatory affairs within the pharmaceutical industry.

Requirements

• Currently pursuing or recently completed a Bachelor’s or Master’s degree in a scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, Regulatory Science, or related field)
• Strong interest in pharmaceutical regulatory affairs and drug development
• Excellent written and oral communication skills
• Strong organizational skills and attention to detail
• Ability to manage multiple tasks and meet deadlines in a fast-paced environment
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Self-motivated with a proactive approach to learning and problem-solving
• Ability to work both independently and collaboratively within a team setting

Nice To Haves

• Familiarity with FDA regulations and ICH guidelines is a plus
• Prior internship or coursework experience in regulatory affairs, quality assurance, or pharmaceutical development is preferred but not required

Responsibilities

• Assist in the preparation, compilation, and review of regulatory submissions, including INDs, NDAs, supplements, amendments, and annual reports
• Support the maintenance and organization of regulatory files, submission tracking logs, and correspondence with the FDA
• Conduct research on FDA regulations, guidance documents, and industry standards relevant to ophthalmic and pharmaceutical products
• Support the review and assessment of change controls for potential regulatory impact
• Assist in monitoring the U.S. regulatory landscape for changes affecting ophthalmic products and summarize findings for the team
• Participate in cross-functional project team meetings and contribute to regulatory discussions
• Help maintain regulatory databases, tracking tools, and internal document management systems
• Support the development and improvement of regulatory SOPs, templates, and processes
• Perform other duties and projects as assigned to support the Regulatory Affairs department

What This Job Offers

• Career Level: Intern
• Number of Employees: 101-250 employees