Regulatory Affairs Intern

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company – where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow’s values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world – providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need.  We encourage you to learn more about Harrow and its unique culture to see if you’re the right person to help contribute as we build a truly exceptional company, one we are all so proud of!

Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:

• An expanding Retina Portfolio including IHEEZO^®, TRIESENCE^®, BYOOVIZ^TM, and OPUVIZ^TM
• A broad Dry Eye Disease product line, led by VEVYE^® and bolstered by well-known adjacent ocular surface disease products such as FLAREX^® and FRESHKOTE^®
• A peri-operative Surgical product line, led by TRIESENCE^®, and BYQLOVI^TM
• A Rare and Specialty product line, which includes various high-need and utility products such as ILEVRO^®, NATACYN^®, and VERKAZIA^®
• A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01

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.

• →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

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

• Remote/Hybrid

• Minimal; up to 10%