Regulatory Affairs Manager, CMC — Ophthalmic Pharma Remote

Harrow; United States; Remote; USD 140,000 - 200,000; Full time

Job summary

Harrow in the United States seeks a Manager of Regulatory Affairs, CMC to lead registration and post-approval strategies for its ophthalmic products. You will collaborate with R&D, Marketing, Clinical, Medical Affairs, Legal, QA and cross-functional teams to drive FDA and global submissions.

You will build and lead the Regulatory function, plan timelines, and ensure lifecycle management. Remote role with up to 30% travel.

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 (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
• Understanding of regulatory CMC requirements relevant to global drug development and post-market support.
• Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.
• Able to deal with issues of essential importance; provide regulatory advice and make reasoned decisions on regulatory issues where guidance may be limited.
• Demonstrate leadership, problem-solving ability, attention to detail, and flexibility, and value teamwork.
• Excellent written and oral communication skills.
• Active participation in Agency/Industry groups/forums preferred.

Responsibilities

• Lead development of regulatory strategies for registration and post-approval commercialization of Harrow’s ophthalmic products.
• Oversee regulatory matters connected to Harrow’s compounded ophthalmic drug formulations, including marketing materials.
• Develop, lead, and drive the execution of regulatory strategy from pre-IND to launch, commercialization, and lifecycle management.
• As a GRA CMC product leader or team member, ensure and enhance regulatory compliance for filing requirements throughout development and lifecycle.
• Independently define CMC content (data and documentation) requirements for submissions and review for conformance with requirements.
• Build and lead the Regulatory function, including hiring, managing, and developing the Regulatory team.
• Plan and execute activities in support of all regulatory submissions.
• Serve as the primary company contact with the US FDA to achieve regulatory objectives, fostering strong relationships.

Skills

Regulatory CMC

Regulatory strategy

FDA liaison

Leadership

Regulatory submissions

Education

BS/BA in science

Tools

Regulatory databases

Job description

Harrow in the United States seeks a Manager of Regulatory Affairs, CMC to lead registration and post-approval strategies for its ophthalmic products. You will collaborate with R&D, Marketing, Clinical, Medical Affairs, Legal, QA and cross-functional teams to drive FDA and global submissions.

You will build and lead the Regulatory function, plan timelines, and ensure lifecycle management. Remote role with up to 30% travel.