Job Description
Role Description
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
- Work 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
- Oversee regulatory matters connected to INDs, NDAs, and OTC ophthalmic products
- As a regulatory product lead, ensure 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
- 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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