Remote RA CMC Leader | Ophthalmic Regulatory Strategy

Harrow, Inc.; Oregon; Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Remote work

Travel up to 30%

Job summary

Harrow, Inc. is seeking a Manager of Regulatory Affairs, CMC to lead regulatory CMC strategies for ophthalmic products. You will collaborate with R&D, QA, Legal, and Marketing to ensure FDA clearance/approval and global registrations. The role involves building the Regulatory function and driving submissions throughout product lifecycles.

The position emphasizes strategic guidance, team leadership, and cross-functional partnership to maintain Harrow’s commitment to patient access and innovation.

Qualifications

• Bachelor-level scientific degree required; advanced degree preferred.
• Excellent written and verbal communication skills.
• Ability to lead cross-functional teams and influence senior leadership.
• Strong regulatory CMC understanding for global drug development.
• Experience guiding submissions from pre-IND to post-market.
• Decision-making with limited regulatory guidance and risk assessment.
• Proven leadership and people management capabilities.

Responsibilities

• Develop regulatory CMC strategies for assigned products.
• Lead regulatory activities for FDA submissions and global regulatory bodies.
• Collaborate with R&D, Marketing, Clinical, Legal, QA and others.
• Define CMC data/document requirements for regulatory submissions.
• Build and lead the Regulatory function including hiring and development.
• Oversee 503A and 503B formulations regulatory matters and marketing materials.
• Plan and drive regulatory submissions and lifecycle management.
• Serve as primary contact with FDA and represent company interests.
• Monitor regulatory landscape and advise on policy changes.

Skills

Leadership

Communication

Regulatory strategy

Problem-solving

Teamwork

Education

BS/BA in scientific discipline

Advanced degree preferred

Job description

Harrow, Inc. is seeking a Manager of Regulatory Affairs, CMC to lead regulatory CMC strategies for ophthalmic products. You will collaborate with R&D, QA, Legal, and Marketing to ensure FDA clearance/approval and global registrations. The role involves building the Regulatory function and driving submissions throughout product lifecycles.

The position emphasizes strategic guidance, team leadership, and cross-functional partnership to maintain Harrow’s commitment to patient access and innovation.