Regulatory Affairs Intern
Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to click this link and get to know us.
Who is Harrow?
Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company ā 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 ā 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:
ā¢ An expanding Retina Portfolio including IHEEZOĀ®, TRIESENCEĀ®, BYOOVIZTM, and OPUVIZTM
ā¢ A broad Dry Eye Disease product line, led by VEVYEĀ® and bolstered by well-known adjacent ocular surface disease products such as FLAREXĀ® and FRESHKOTEĀ®
ā¢ A peri-operative Surgical product line, led by TRIESENCEĀ®, and BYQLOVITM
ā¢ A Rare and Specialty product line, which includes various high-need and utility products such as ILEVROĀ®, NATACYNĀ®, and VERKAZIAĀ®
ā¢ A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01
Job Summary 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.
Core Responsibilities
ā¢ Assist in the preparation, compilation, and review of regulatory submissions, including INDs, NDAs, supplements, amendments, and annual reports
ā¢ Support the maintenance and organization of regulatory files, submission tracking logs, and correspondence with the FDA
ā¢ Conduct research on FDA regulations, guidance documents, and industry standards relevant to ophthalmic and pharmaceutical products
ā¢ Support the review and assessment of change controls for potential regulatory impact
ā¢ Assist in monitoring the U.S. regulatory landscape for changes affecting ophthalmic products and summarize findings for the team
ā¢ Participate in cross-functional project team meetings and contribute to regulatory discussions
ā¢ Help maintain regulatory databases, tracking tools, and internal document management systems
ā¢ Support the development and improvement of regulatory SOPs, templates, and processes
ā¢ Perform other duties and projects as assigned to support the Regulatory Affairs department
Qualifications & Requirements
ā¢ 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)
ā¢ Strong interest in pharmaceutical regulatory affairs and drug development
ā¢ Familiarity with FDA regulations and ICH guidelines is a plus
ā¢ Excellent written and oral communication skills
ā¢ Strong organizational skills and attention to detail
ā¢ Ability to manage multiple tasks and meet deadlines in a fast-paced environment
ā¢ Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
ā¢ Self-motivated with a proactive approach to learning and problem-solving
ā¢ Ability to work both independently and collaboratively within a team setting
ā¢ Prior internship or course
Apply tot his job
Apply To this Job
Who is Harrow?
Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company ā 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 ā 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:
ā¢ An expanding Retina Portfolio including IHEEZOĀ®, TRIESENCEĀ®, BYOOVIZTM, and OPUVIZTM
ā¢ A broad Dry Eye Disease product line, led by VEVYEĀ® and bolstered by well-known adjacent ocular surface disease products such as FLAREXĀ® and FRESHKOTEĀ®
ā¢ A peri-operative Surgical product line, led by TRIESENCEĀ®, and BYQLOVITM
ā¢ A Rare and Specialty product line, which includes various high-need and utility products such as ILEVROĀ®, NATACYNĀ®, and VERKAZIAĀ®
ā¢ A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01
Job Summary 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.
Core Responsibilities
ā¢ Assist in the preparation, compilation, and review of regulatory submissions, including INDs, NDAs, supplements, amendments, and annual reports
ā¢ Support the maintenance and organization of regulatory files, submission tracking logs, and correspondence with the FDA
ā¢ Conduct research on FDA regulations, guidance documents, and industry standards relevant to ophthalmic and pharmaceutical products
ā¢ Support the review and assessment of change controls for potential regulatory impact
ā¢ Assist in monitoring the U.S. regulatory landscape for changes affecting ophthalmic products and summarize findings for the team
ā¢ Participate in cross-functional project team meetings and contribute to regulatory discussions
ā¢ Help maintain regulatory databases, tracking tools, and internal document management systems
ā¢ Support the development and improvement of regulatory SOPs, templates, and processes
ā¢ Perform other duties and projects as assigned to support the Regulatory Affairs department
Qualifications & Requirements
ā¢ 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)
ā¢ Strong interest in pharmaceutical regulatory affairs and drug development
ā¢ Familiarity with FDA regulations and ICH guidelines is a plus
ā¢ Excellent written and oral communication skills
ā¢ Strong organizational skills and attention to detail
ā¢ Ability to manage multiple tasks and meet deadlines in a fast-paced environment
ā¢ Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
ā¢ Self-motivated with a proactive approach to learning and problem-solving
ā¢ Ability to work both independently and collaboratively within a team setting
ā¢ Prior internship or course
Apply tot his job
Apply To this Job