Ophthalmic Regulatory Affairs Lead, CMC & Strategy

harrowhealth; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Harrow Health seeks a Manager of Regulatory Affairs, CMC to lead regulatory registration and post-approval strategies for Harrow's ophthalmic products. This role collaborates with R&D, Marketing, Clinical, Medical Affairs, Legal, QA and others to craft strategies guiding FDA clearance/approval and other global agencies.

Responsibilities include developing regulatory strategies from pre-IND to launch, overseeing CMC submissions for 503A/503B formulations, building the Regulatory function, and

Qualifications

• BS/BA degree in a scientific discipline; advanced degree preferred.
• 6+ years of pharmaceutical regulatory CMC experience, including experience as an RA CMC product lead, or equivalent industry experience.

Responsibilities

• Lead development of regulatory strategies and objectives for registration and post-approval commercialization.
• Oversee regulatory matters related to Harrow's compounded ophthalmic drug formulations (503A/503B), including marketing materials.
• Develop and drive regulatory strategy from pre-IND to launch and lifecycle management.
• Ensure conformance of data/documentation with regulatory requirements for submissions.
• Build and lead a Regulatory team, including hiring and development.
• Plan and execute regulatory submissions across programs and products.
• Serve as primary contact with US FDA to advance regulatory objectives and advocate for Harrow Health.

Education

BS/BA in scientific discipline

Job description

Harrow Health seeks a Manager of Regulatory Affairs, CMC to lead regulatory registration and post-approval strategies for Harrow's ophthalmic products. This role collaborates with R&D, Marketing, Clinical, Medical Affairs, Legal, QA and others to craft strategies guiding FDA clearance/approval and other global agencies.

Responsibilities include developing regulatory strategies from pre-IND to launch, overseeing CMC submissions for 503A/503B formulations, building the Regulatory function, and