Regulatory Affairs Manager, CMC

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

Who is Harrow?

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company - where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow's values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world - providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need . We encourage you to learn more about Harrow and its unique culture to see if you're the right person to help contribute as we build a truly exceptional company, one we are all so proud of!

Harrow's ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:

• An expanding Retina Portfolio including IHEEZO ® , TRIESENCE ® , BYOOVIZ TM , and OPUVIZ TM
• A broad Dry Eye Disease product line , led by VEVYE ® and bolstered by well-known adjacent ocular surface disease products such as FLAREX ® and FRESHKOTE ®
• A peri-operative Surgical product line , led by TRIESENCE ® , and BYQLOVI TM
• A Rare and Specialty product line , which includes various high-need and utility products such as ILEVRO ® , NATACYN ® , and VERKAZIA ®
• A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01

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, Anal