Regulatory Affairs Manager, CMC

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

Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to click this link and get to know us.

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:

• 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, 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%

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Harrow, Inc.’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.