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Regulatory Affairs Manager, CMC & Clinical Development

United States

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 – 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®, BYOOVIZTM, and OPUVIZTM
  • 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 BYQLOVITM
  • 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

Job Summary

The Manager of Regulatory Affairs will develop and execute regulatory strategies across the product lifecycle, including early-stage development, IND submissions, clinical trial support, NDA filings, and post-approval CMC activities. This role will lead regulatory CMC strategy while also serving as a key regulatory partner to Clinical Development for IND preparation, clinical trial applications, FDA interactions, and lifecycle management.

The position collaborates cross-functionally with R&D, Clinical, Medical Affairs, Legal, QA, Manufacturing, and Commercial teams to ensure successful product development, regulatory approval, and compliance with FDA and global regulatory requirements.

Core Responsibilities

  • Lead preparation, review, and submission of IND applications (including original INDs, amendments, annual reports, and safety updates)
  • Develop a regulatory strategy to support clinical development plans, including Phase 1–3 trial progression
  • Provide regulatory guidance for clinical protocol development and ensure alignment with FDA expectations
  • Lead and support FDA interactions, including Pre-IND, End-of-Phase, and other Type B/C meetings
  • Partner with Clinical and Medical teams to assess regulatory risk and develop mitigation strategies
  • Ensure compliance with GCP and applicable clinical regulatory requirements
  • Works closely with the executive leadership team to lead the development of regulatory strategies and objectives that result in successful registration and commercialization of Harrow’s ophthalmic products
  • Oversees regulatory matters connected to INDs, NDAs, and OTC ophthalmic products
  • As a regulatory product lead, ensures alignment of CMC, nonclinical, and clinical components to support successful IND, NDA, and post-approval submissions
  • Independently define CMC content (data and documentation) requirements for regulatory submissions and review content for conformance with established requirements
  • Plan and execute activities in support of INDs, NDAs, supplements, amendments, annual reports, and other regulatory submissions
  • Review and assess change controls for regulatory impact and manage appropriate submission requirements
  • Review and assess promotional materials for adherence to FDA guidance and current thinking
  • Serve as a primary contact with the US FDA, fostering strong relationships and acting as an effective regulatory advocate for Harrow Health
  • Provide regulatory guidance across all functional areas
  • Develop robust regulatory structures, processes, and procedures based on expert understanding and industry insight
  • Monitor the US regulatory landscape for changes affecting ophthalmic products and communicate impact to stakeholders

 

Qualifications & Requirements 

  • BS/BA Degree in a Scientific Discipline, an advanced degree preferred.
  • 6+ years of pharmaceutical Regulatory Affairs experience, including:
  • Direct experience authoring or leading IND submissions
  • Regulatory support for clinical trial programs (Phase 1–3)
  • CMC regulatory strategy and lifecycle management experience
  • Demonstrated experience interacting with the FDA on clinical development programs
  • Strong working knowledge of IND content requirements (Modules 2–5), ICH guidelines, and GCP regulations
  • Experience preparing briefing documents and participating in FDA meetings (Pre-IND, Type B, etc.)
  • Experience with NDA preparation and/or post-approval regulatory activities preferred
  • Experience supporting early-phase drug development and first-in-human studies strongly preferred
  • Ability to provide strategic regulatory guidance across development stages
  • Strong problem-solving ability, attention to detail, flexibility, and teamwork orientation
  • Excellent written and oral communication skills
  • Active participation in Agency/Industry groups/forums preferred

 

Position Type

 

  • Remote

 

Travel

 

  • Up to 30%

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