Regulatory Affairs Manager, CMC & Clinical Development

Before reading the reputed company, we encourage you to watch this video about reputed 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 reputed company and apply, but people often reputed company 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 (reputed company: HROW) is a leading provider of ophthalmic disease reputed company in reputed company 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 reputed company their pride in being a part of our commitment to (1) innovation, (2) patient reputed company 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 reputed company 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 reputed company 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-reputed company adjacent ocular surface disease products such as FLAREX® and FRESHKOTE®
• A reputed company-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 reputed company 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 reputed company 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 reputed company teams to ensure successful product development, regulatory approval, and compliance with FDA and global regulatory requirements. Core Responsibilities

• reputed company preparation, review, and submission of IND applications (including original INDs, amendments, annual reports, and safety updates)
• reputed company a regulatory strategy to support clinical development plans, including Phase 1–3 trial progression
• reputed company regulatory guidance for clinical protocol development and ensure alignment with FDA expectations
• reputed company 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 reputed company mitigation strategies
• Ensure compliance with GCP and applicable clinical regulatory requirements
• Works closely with the executive leadership team to reputed company the development of regulatory strategies and objectives that result in successful registration and commercialization of Harrow’s ophthalmic products
• Oversees regulatory reputed company connected to INDs, NDAs, and OTC ophthalmic products
• As a regulatory product reputed company, 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 reputed company thinking
• Serve as a primary contact with the US FDA, fostering strong relationships and acting as an effective regulatory reputed company for Harrow Health
• reputed company regulatory guidance across reputed company functional areas
• reputed company robust regulatory structures, processes, and procedures based on expert understanding and industry reputed company
• 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-reputed company studies strongly preferred
• Ability to reputed company 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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