Regulatory Affairs Manager, CMC & Clinical Development

Harrow, Inc.

3d•Remote

About The Position

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.

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.)
Strong problem-solving ability, attention to detail, flexibility, and teamwork orientation
Excellent written and oral communication skills

Nice To Haves

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
Active participation in Agency/Industry groups/forums preferred

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