Regulatory Affairs Manager, CMC

Harrow, Inc.

11h•Remote

About The Position

The Manager of Regulatory Affairs, CMC develops and leads regulatory CMC registration and post-approval strategies for assigned products. The role leads regulatory affairs activities for Harrow’s ophthalmic unit, including product registration and compliance, and collaborates with R&D, Marketing, Clinical, Medical Affairs, Legal, QA, and other functional areas. The manager provides regulatory expertise to develop strategies that guide products through FDA clearance or approval and the processes of other global regulatory agencies. The position also oversees regulatory matters related to Harrow’s 503A and 503B compounded ophthalmic drug formulations, builds and leads the Regulatory function, and serves as the primary company contact with the US FDA. It is remote and requires travel of up to 30%.

Requirements

BS/BA degree in a scientific discipline.
At least 6 years of pharmaceutical regulatory CMC experience, including experience as an RA CMC product lead, or equivalent industry experience such as Pharmaceutical Development, Analytical Development, Production, or 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.
Ability to address issues of essential importance and make reasoned regulatory decisions when clear or specific guidance may not exist.
Leadership, problem-solving ability, attention to detail, flexibility, and teamwork.
Good judgment in elevating and communicating actual or potential issues to line management.
Excellent written and oral communication skills.

Nice To Haves

Advanced degree.
Active participation in Agency/Industry groups or forums.

Responsibilities

Work with executive leadership to develop regulatory strategies and objectives supporting registration and post-approval commercialization of Harrow’s ophthalmic products.
Oversee regulatory matters for Harrow’s 503A and 503B compounded ophthalmic drug formulations, including supervision of marketing-material development.
Develop and drive regulatory strategy from pre-IND through launch, commercialization, and product lifecycle management.
As a GRA CMC product leader or team member, ensure and enhance compliance with filing requirements for assigned compounds throughout development and the commercial lifecycle.
Define CMC data and documentation requirements for regulatory submissions and review content for conformance with established requirements.
Build and lead the Regulatory function, including hiring, managing, and developing the Regulatory team.
Plan and execute activities supporting regulatory submissions.
Serve as the primary company contact with the US FDA, fostering relationships and advocating effectively for Harrow Health’s regulatory objectives.
Provide regulatory guidance to company personnel throughout all stages of product development.
Develop regulatory structures, processes, procedures, and budget forecasts based on regulatory expertise and industry experience.
Monitor US regulatory policy, regulation, and guidance affecting ophthalmic products; work with management to assess impacts and communicate guidance to stakeholders.