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Regulatory Affairs Manager, CMC at Harrow, Inc. - ApplyBlast

Regulatory Affairs Manager, CMC

Harrow, Inc.

6 hours ago

Remote

Full Time

Manager

0 applicants

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About this role

The Regulatory Affairs Manager, CMC leads the execution of regulatory CMC registration and post-approval strategies for Harrow's ophthalmic products. This role involves collaborating with cross-functional teams to develop regulatory strategies that guide products through FDA clearance and global agency approvals. The position also oversees regulatory compliance for compounded drug formulations and manages the regulatory team.

Responsibilities

Lead regulatory CMC registration and post-approval strategies for assigned products
Oversee regulatory matters for compounded ophthalmic drug formulations and marketing materials
Serve as primary company contact with the US FDA to achieve regulatory objectives

Skills

About Harrow, Inc.

harrow.com

Headquarters

Nashville, Tennessee, United States

Company Size

201-500 employees

Founded

2012

View Profile

Harrow, Inc. is a healthcare company that develops, acquires, and commercializes specialty pharmaceuticals and patient-focused services. It emphasizes improving patient outcomes and access to therapies through clinical development, commercialization efforts, and provider support programs. Harrow works with healthcare partners, payers, and clinicians to bring treatments to market and support their appropriate use. Its investor relations site provides financial reports, corporate news, and governance information for stockholders and analysts.