Regulatory Affairs Manager, CMC

Position Summary 

The Manager of Regulatory Affairs, CMC will develop and lead the execution of regulatory CMC registration and post-approval strategies for assigned products. The position will lead and direct regulatory affairs activities for the Harrow ophthalmic unit, including product registration and compliance objectives. The Manager of RA must be able to collaborate effectively with R&D, Marketing, Clinical, Medical Affairs, Legal, QA, and other functional areas, and provide regulatory expertise to effectively develop regulatory strategies that successfully lead products through the FDA clearance/approval process, as well as other global regulatory agencies. 

Core Responsibilities 

• Work closely with the executive leadership team to lead the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of Harrow’s ophthalmic products. 

• Oversee all regulatory matters connected to Harrow’s suite of 503A and 503B compounded ophthalmic drug formulations, including supervising the development of all marketing materials. 

• Develop, lead, and drive the execution of the regulatory strategy from pre-IND to launch, commercialization, and product lifecycle management. 

• As a GRA CMC product leader or team member, ensure and enhance regulatory compliance for filing requirements for assigned compounds throughout development and the commercial lifecycle. 

• Independently define CMC content (data and documentation) requirements for regulatory submissions and review this content for conformance with established 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 company regulatory objectives, fostering strong relationships and acting as a credible, reputable, and effective advocate for Harrow Health. 

• Provide regulatory guidance to company personnel across all areas of regulatory affairs throughout all stages of product development. 

• Develop robust regulatory structures, processes, and procedures, and budget forecasting based on expert understanding, industry experience, and insight into the future direction of regulatory policy. 

• Monitor the US regulatory landscape for changes in policy, regulation, or guidance affecting ophthalmic products; work with management to analyze changes, determine internal impact, and communicate and provide guidance to all impacted key stakeholders. 

Qualifications & Requirements 

• 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 scientific principles and 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 for which there may not be clear/specific regulatory guidance. 

• Demonstrate leadership, problem-solving ability, attention to detail, and flexibility, and value teamwork. 

• Exercise good judgment in elevating and communicating actual or potential issues to line management. 

• Excellent written and oral communication skills. 

• Active participation in Agency/Industry groups/forums preferred. 

Position Type 

• Remote 

Travel 

• Up to 30%