Remote Ophthalmic CMC Regulatory Lead

Harrow, Inc.; United States; Remote; USD 150,000 - 200,000; Full time

Job summary

Harrow, Inc. in the United States is seeking a Manager of Regulatory Affairs, CMC to lead regulatory CMC submissions and post-approval strategies for its ophthalmic portfolio.

You will collaborate with R&D, Marketing, Clinical, Medical Affairs, Legal, QA, and other teams to navigate FDA clearance/approval and global regulatory pathways. You will build and lead a Regulatory function, plan submissions from pre-IND through launch, manage 503A/503B product lines, and maintain strong relationships

Qualifications

• BS/BA in a scientific discipline; advanced degree preferred.
• 6+ years of pharmaceutical regulatory CMC experience.
• Strong regulatory knowledge for global drug development and post-market support.
• Experience guiding drug development, registration, and lifecycle support.
• Ability to provide regulatory advice and make decisions under uncertainty.
• Demonstrated leadership and teamwork; strong communication.

Responsibilities

• Lead the development of regulatory strategies to register and commercialize ophthalmic products.
• Oversee regulatory matters for 503A/503B compounded formulations and marketing materials.
• Drive pre-IND to launch regulatory planning and lifecycle management.
• Define CMC content requirements and ensure conformance with requirements.
• Build, hire, and develop the Regulatory team.
• Plan and execute regulatory submissions across programs.
• Serve as primary FDA contact to achieve regulatory objectives.
• Provide regulatory guidance across all stages of product development.
• Develop robust regulatory structures, processes, and budget forecasting.
• Monitor US regulatory changes and advise stakeholders.

Skills

Regulatory CMC

Leadership

Regulatory strategy

Communication

Education

Science degree

Advanced degree preferred

Job description

Harrow, Inc. in the United States is seeking a Manager of Regulatory Affairs, CMC to lead regulatory CMC submissions and post-approval strategies for its ophthalmic portfolio.

You will collaborate with R&D, Marketing, Clinical, Medical Affairs, Legal, QA, and other teams to navigate FDA clearance/approval and global regulatory pathways. You will build and lead a Regulatory function, plan submissions from pre-IND through launch, manage 503A/503B product lines, and maintain strong relationships